for use in research only

• Lupe_Grau Cancel

Laboratory Products for “Research Use Only” (RUO) – Often a Dangerous Claim

Manufactures use the “Research Use Only” (RUO) label to declare that their products should not be used in diagnostic procedures. This enables them to avoid the time-consuming and costly documentation required for conformity-assessed in vitro diagnostic medical devices (CE-IVDs). Nevertheless, some medical laboratories, for example, still use RUO products in diagnostic procedures, sometimes even with the knowledge of the manufacturers. This can have consequences – not just for manufacturers and operators, but for patients as well.

In this article, you will learn:

• What the “Research Use Only” label (RUO) means
• What the requirements for RUO products are
• How to avoid legal problems
• What alternatives there are to RUO products

1. “Research Use Only” – what does it mean?

Labeling products for “research use only” has far-reaching consequences. It means the products are barely subject to any regulatory controls under the IVDR. As a result, for a lot of manufacturers and operators, they are desirable alternatives to more costly and time-intensive conformity-assessed in-vitro diagnostic medical devices (CE-IVDs) that must comply with the applicable legal requirements.

a) Institutions affected

The following institutions, in particular, use RUO products:

• Medical laboratories can use RUO products, but this makes them the manufacturer with all the consequences this entails. You can find more information on “lab developed tests” in our article “ The E U Regulates Medical Laboratories. Are Laboratory Developed Tests Still Allowed? ”
• If medical laboratories use RUO products for purposes other than research then, in the worst case, this makes them liable for damages as well as criminally liable.
• Therefore, medical laboratories should inform themselves about the parameters for RUO products and possible alternatives .
• Manufacturers Manufacturers use RUO products as components for their IVDs. They should, therefore, make sure that they know all the requirements in detail before labeling a product as “RUO”.

b) Definition

There is no uniform definition of “research use only” products. In general, they can be understood to be what the name implies, i.e., products to be used for analysis that are intended to be used for scientific research purposes only.

They primarily differ from medical devices in that they cannot be used for medical purposes.

However, the understanding of “research use only” is different in Europe and the USA.

Definition in Europe

In Europe, the MEDDEV 2.14/2 guidance document (IVD Guidance: Research Use Only products – A guide for manufacturers and notified bodies) provides clues as to the definition of RUOs. This guidance was written within the framework of the now obsolete Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) and, in the absence of an up-to-date replacement, it can still be considered the state of the art.

MEDDEV 2.14/2 states:

“for a product to be categorized as an RUO product it must have no intended medical purpose or objective."

Source: MEDDEV 2.14/2 rev.1

This means that an RUO product must not have even a rudimentary medical purpose.

However, in the case of tests developed in-house by a laboratory (LDTs), this restriction does not apply provided that the products are not sold to other companies. The guidance gives the following specific examples of LDTs that may be designated “research use only” under this requirement:

• PCR enzymes
• Gel component agars

The IVDR also addresses RUO products.

“device for performance study’ means a device intended by the manufacturer to be used in a performance study.

A device intended to be used for research purposes, without any medical objective, shall not be deemed to be a device for performance study; ”

Source: IVDR Art. 2(45)

Thus, the IVDR, like MEDDEV 2.14/1 (IVD Medical Device Borderline and Classification issues), draws a distinction between RUO products and “devices for performance studies.”

Again, the key aspect of the definition is the RUO product’s lack of medical purpose.

To be classed an RUO product, it is vital that the product does not serve a medical purpose. Even a suspected medical purpose is enough for a device to be no longer considered an RUO product.

(See MEDDEV 2.14/1 section 1.1 4.)

Definition in the USA

In 2013, the FDA published a guidance document on RUOs entitled “Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only.”

This guidance defines RUO products as follows:

“ An RUO product is an IVD product that is in the laboratory research phase of development and is being shipped or delivered for an investigation that is not subject to part 812” [NB: Part 812 concerns the provision of devices for performance evaluation purposes as a preliminary step to IVDs]

Source: FDA guidance “Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only”

Some examples of products that the FDA believes fall into this research phase of development are:

• Tests that are in development to identify test kit methodology, necessary components, and analytes to be measured
• Instrumentation, software, or other electrical/mechanical components under development to determine correct settings, subcomponents, subassemblies, basic operational characteristics, and possible use methods
• Reagents under development to determine production methods, purification levels, packaging needs, shelf life, storage conditions, etc.

Therefore, according to the FDA, a clearly visible RUO label must be affixed specifically to products that are in a research phase.

c) What are the consequences of using the “Research Use Only” label?

Normally, IVDs are subject to regulatory requirements (for example, according to the IVDR or FDA) based on their risk class.

However, RUO products do not fall within the definition of “in vitro diagnostic medical devices” given by the IVDR or the relevant FDA regulations . This means that these regulations do not apply to RUO products.

Definition: In vitro diagnostic medical devices (IVDs) in the EU

“‘In vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:

(a) concerning a physiological or pathological process or state;

(b) concerning congenital physical or mental impairments;

(c) concerning the predisposition to a medical condition or a disease;

(d) to determine the safety and compatibility with potential recipients;

(e) to predict treatment response or reactions;

(f) to define or monitoring therapeutic measures.

Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices;”

Source: Article 2 IVDR

Definition: In vitro diagnostic medical devices (IVDs) in the USA

“In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.”

Source: 21 CFR 809.3

Therefore, the requirements of the IVDR do not apply to RUO products. In the USA, they are exempt from cGMP and the FDA's quality regulations.

Depending on the product, they may still have to comply with requirements that are not specifically intended for IVDs (such as the REACH regulation for chemicals or the Machinery Directive ).

Since RUO products are thus subject to considerably fewer controls than IVDs, it is necessary to severely restrict their use.

Therefore, in particular they may not be used to:

• Make diagnoses
• Conduct performance studies

2. Use and misuse of “Research Use Only” labels

A) what should ruo products be used for.

As the name “research use only” indicates, products with RUO labeling are intended for research purposes only. RUO products are particularly attractive for the research sector due to the simplified process and lower hurdles for placing them on the market.

MEDDEV. 2.14/2 rev.1 provides a precise list of areas where RUO products may potentially be used:

• Basic research
• Pharmaceutical research
• Better identification and quantification of individual chemical substances or ligands in biological specimens
• In house manufacturing of so called “home brew kits” for research purposes

And of areas where the use of RUOs is expressly not permitted:

• Use of raw materials which are labeled “for “research use only” but which are incorporated into a finished product
• So called “research use” products being tested against a comparator IVD product that bears the CE mark
• Products for market studies/ feasibility studies

b) What RUO products are often used for

However, the low hurdles are also the reason why RUO products are often used for purposes they are not intended for. This poses significant dangers for manufacturers, operators and patients.

Sale of RUO products to medical laboratories

RUO products are sold by manufacturers to medical laboratories. Although doctors sometimes also conduct research, this is not really the main purpose of a medical laboratory. Therefore, when discussing sales with doctors, it should always be assumed that there is a medical reason behind the use of the product.

This means that anyone who knowingly sells RUO products to medical laboratories is potentially under suspicion of using the pretext “for research use only” to ignore an intended medical purpose and thus avoid responsibility for a medical device.

There are certainly laboratory products that clearly have no specific medical purpose, e.g.:

• Nutrient media
• Reaction vessels
• Washing solutions

These products are best labeled as “general laboratory supplies” rather than “RUO”.

Avoid reference to any specific diagnostic procedures in your advertising materials for products that clearly do not have a medical purpose. You should always stay on the technical or purely analytical level.

The issue with analyte specific reagents

Whether an RUO product contains analyte specific reagents, e.g., primary antibodies, FISH probes, PCR primers and probes, and sequencing panels, can be critical. In some cases, a medical purpose can be inferred just from the description of the product's performance.

This would be the case if a manufacturer of a RUO-labeled kit for the detection of viral genes specifies a number of copies per ml of blood that the kit can detect.

ASR in the USA

The FDA abbreviates the term “analyte specific reagents” to “ASR” and defines it as follows:

“Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens.”

Source: 21CFR864.4020 a)

In other words, US law says that, by definition, ASRs have a diagnostic purpose.

Exception: The sale of ASRs to IVD manufacturers as components for manufacturing kits or to non-clinical laboratories for research and development without compliance with regulatory requirements is permitted.

ASR in the EU EU law does not contain this exception. Nor does the term “analyte specific reagent” does appear in any of the applicable EU regulations. Therefore, such products may have a general laboratory purpose in the EU, depending on the justification. This means they do not fall under the IVDR if the manufacturer defines the intended purpose accordingly.   However, if the manufacturer assigns a medical or diagnostic purpose to these products, the regulatory hurdles will very high once the IVDR comes into full effect (currently scheduled for May 26, 2022).

This means that the crucial factor is whether manufacturers have clearly defined the intended purpose and whether communication with customers (e.g., in advertising materials) is in line with this purpose.

Further information

You can find out more about the intended purpose of medical devices here: Intended purpose and intended use

Use of RUO products in medical laboratories

It is not just manufacturers for whom the sale of RUOs to medical laboratories represents a problem. The laboratories themselves may also not be acting in line with their status as operators and may, as a result, be liable under certain circumstances.

• Medical laboratories are free to develop in-house tests themselves. In such cases, RUO products are often used in diagnostic procedures. Even under the IVDD, MEDDEV 2.14/2 was critical of this. However, with the new In Vitro Diagnostic Medical Device Regulation (IVDR) , the EU is explicitly placing more restrictions on the routine use of such lab developed tests . Read more in our article The EU Is Regulating Medical Laboratories. Are Laboratory Developed Tests Still Allowed? .
• Due to the low regulatory hurdles, purchasing RUO products is very affordable. As a result, medical laboratories prefer them over expensive CE-IVD devices if they can achieve the same level of performance. Nevertheless, the use of RUO products for purposes other than research, even in cases where they provide similar results, is not permitted.

3. Consequences of incorrect classification

Lack of controls can have a negative effect on quality. As a result, the relevant bodies (e.g., authorities during inspections) take a closer look at whether a product is actually intended for “research use only”.

Manufacturers should also be aware that simply sticking an RUO label on a product does not on its own mean that the product no longer has to comply with requirements for IVDs that would otherwise apply.

In its guidance document on RUO , the FDA writes that only the actual intended use qualifies a product as RUO – or doesn’t. The FDA also uses marketing materials or other general factors as evidence of the intended purpose.

"Because these products are exempt from most regulatory controls, it is important that they are not distributed for clinical diagnostic uses. Mere placement of an RUO or IUO label on an IVD product does not render the device exempt from otherwise applicable clearance, approval, or other requirements. FDA may determine that the device is intended for use in clinical diagnosis based on other evidence, including how the device is marketed. ”

Manufacturers and operators who misuse the RUO label could face severe penalties, as such behavior can cause serious harm to patients or even the general public.

a) Consequences for manufacturers and operators

Improperly selling IVDs with an RUO label or using RUO products for purposes other than research is not a trivial offense.

Manufacturers who demonstrably hide or aim to hide a diagnostic purpose behind the RUO label should expect legal consequences in Germany. The same applies for operators who misuse RUO products. There is the possibility of a fine or even prison sentences. In addition, there is potential liability for harm suffered by patients.

b) Consequences in the USA

There are also severe penalties in the USA. If an RUO label is deemed to have been incorrectly used for a product, the product would be considered misbranded under sections 502(a) and 502(o) of 21 US Code, 352(a), 352(o) [A1] and would be considered adulterated under section 501(f) of 21 US Code 351(f).

c) Consequences for patients

However, the consequences can be even worse for patients. After all, the regulatory requirements for IVDs aren’t just plucked out of thin air to annoy manufacturers and operators. The regulations are intended to protect patients against incorrect results and subsequent wrong decisions. False-negative results can lull patients into a false sense of security and an existing disease may worsen undetected. One example would be the metastasis of an undetected cancer due to a test not performing as intended.

Some incorrect diagnoses could even be so severe that they can cause the death of a lot of people: an undetected viral infection can cost many lives in the early stages of an epidemic or pandemic, as the coronavirus pandemic sadly demonstrated.

4. Alternatives to “research use only” products

To avoid legal problems and risks for third parties, manufacturers and users should use alternatives to RUO products in borderline cases.

These alternatives don’t always have to be CE-IVDs. Depending on the specific situation, the following alternatives can be considered based on the intended purpose:

a) Products for general laboratory use

According to the MEDDEV 2.14/1 (IVD Medical Device Borderline and Classification Issues) guidance, it is a product's characteristics that determine whether it can be classified as a product for general laboratory use or not.

• If, based on its characteristics, a product is not specifically intended to be used for in vitro diagnostic examinations, it is not an IVD.
• Manufacturers cannot label products for general laboratory use as IVDs.

RUO products used for a better identification and quantification of individual chemical substances or ligands in biological specimens

Source: MEDDEV 2.14/2

Such products must have a general use. However, use as an IVD does not have to be ruled out, provided the product is not made specifically for a particular test. According to MEDDEV 2.14/2, even the aforementioned analyte specific reagents (ASRs) without a medical purpose fall into this category.

There are several advantages to using products for general laboratory use instead of RUO products:

• The product does not fall under the IVD Directive or the IVDR, which saves you a lot of time and money.
• Laboratories that use these products for in-house procedures are not in danger of being accused of using RUO products in routine diagnostic procedures.

However, the disadvantage is that the medical laboratory is responsible for ensuring that the examination conforms with the IVDR. This can make the product less interesting because the regulatory requirements entail a lot of work.

b) Lab developed tests with class A CE-IVDs Manufacturers may sell general laboratory reagents, which can be authorized as IVDs under the IVDR, to medical laboratories.

In combination with the ASRs developed in-house, laboratories can validate and use these products as lab developed tests (LDTs).

Read our article on lab developed tests to find out what laboratories should be aware of.

c) “For performance evaluation only” as a preliminary stage for certified IVDs

The IVDR defines " device for performance studies ” as follows:

“‘Device for performance study’ means a device intended by the manufacturer to be used in a performance study.”

Source: IVDR 2017/746/EU

These devices must already be safe, as far as possible, and meet the relevant general safety and performance requirements.

5. Ways to protect yourself

Manufacturers, operators and patients can take the following steps to avoid legal and other negative consequences when using RUO products:

a) Manufacturers

In the case of manufacturers, it is particularly important that they narrowly define the intended purpose of their product.

Analyte specific reagents should only be labeled as RUO products for specific non-medical purposes.

Example: SARS-CoV-2 and its mutations: a test kit that uses specific primers and probes to distinguish the variants B.1.1.7 (alpha variant) and B.1.351 (beta variant) from the initial variant following a positive result may be an RUO product if it is only intended to be used to determine the prevalence of the variant in the population. A specific intended purpose in this case would be: “Intended solely for epidemiological research for the purpose of surveying the prevalence of SARS-CoV-2 variants in the general population.” If a medical laboratory subsequently, based on new findings, used this test to provide the best possible treatment for infection by a specific variant, this would be an off-label use. The laboratory would then be responsible for the test's conformity.

Provided the manufacturer did not advertise the product with this clinical benefit, it would be adequately protected.

b) Operators

Operators should record exactly what they use IVDs and RUO products for.

Medical laboratories are operators of medical devices and IVDs and, therefore, are responsible for only using medical devices according to their intended purpose and in accordance with the generally accepted rules of the technology. This is stipulated in Section 4 of the German Medizinprodukte-Betreiberverordnung (MPBetreibV (German)). To be on the safe side, laboratories should keep a record of which medical devices and IVDs are in operation and routine use. This record should include a reference to the applicable test procedure and the intended purpose of the IVD.

This record can also be used to identify investigational procedures for which there are no adequate CE-IVDs available on the market. The lack of alternatives would justify the use of RUOs (as lab developed tests) in validated processes it has developed in-house, provided that the laboratory checks and can demonstrate that the general safety and performance requirements and the additional requirements of Article 5(5) of the IVDR are met.

Read more about the requirements for LDTs in our article on the topic .

c) Patients

Patients lack the knowledge to recognize what is and isn’t an RUO on their own. They are often given little to no information about the test they are undergoing. So, patients should follow this basic rule: ask your doctor or pharmacist!

• Patients can ask for the complete test report from the laboratory so that they can get a second opinion in case of doubt. The report should also indicate which specific test was performed.
• Patients should inform themselves about how “well” or “poorly” a test works, as well as the benefit-risk ratio.
• In the future, patients and doctors will also be able to get information about medical devices from EUDAMED and use this information to decide whether or not the test was performed with certified and thus legally compliant IVDs.

6. Conclusion

In the opinion of the EU Commission and the FDA, products “for research use only" have no place in diagnostics. To be used for diagnostic purposes, products have to go through the necessary controls. But these controls do not apply to RUO products.

Anyone who ignores this prohibition and uses or sells RUO products for purposes other than pure research is playing with fire. Manufacturers and operators run the risk of legal trouble and could even endanger patients’ health. Therefore, RUO products should only be used for research purposes. For other uses, manufacturers and operators should use the alternatives mentioned.

Our tip is: if you, as a manufacturer or medical laboratory, find that an RUO product is particularly well-suited for in vitro diagnostics, consider whether further development and conformity assessment to make it an IVD is worthwhile. We will be happy to help you work out which of the three alternatives to RUOs mentioned above is the best alternative to your product as part of our IVD authorization strategy consultation. If necessary, we can also help you ensure your product development conforms with the regulations.

Dr. Diana Gabriel

A quick overview: Our

Starter-Kit

Always up to date: Our

Back To Top

Privacy settings

We use cookies on our website. Some of them are essential, while others help us improve this website and your experience.

Individual Cookie Settings

Only accept required cookies.

Privacy Notes Imprint

Here is an overview of all cookies use

Required Cookies

These cookies are needed to let the basic page functionallity work correctly.

Show Cookie Informationen

Hide Cookie Information

Provide load balancing functionality.

Provides functions across pages.

Hubspot Forms

Used for the google recaptcha verification for online forms.

Cookies for Statistics

Statistic cookies anonymize your data and use it. These information will help us to learn, how the users are using our website.

Google Analytics

Tracking and analys of traffic on our websites.

Cookies for Marketing

Marketing cookies from thrid parties will be used to show personal advertisment. They use them to track users outside of their own web page.

Keeping track of a visitor's identity. It is passed to HubSpot on form submission and used when deduplicating contacts. It contains an opaque GUID to represent the current visitor. It also introduces cookies from linked in for marketing reasons.

LinkedIn conversion tracking.

Cookies for external Content

Content for Videoplatforms und Social Media Platforms will be disabled automaticly. To see content from external sources, you need to enable it in the cookie settings.

Google Maps

Used to display google maps on our Websites. Google uses cookies to identify and track users.

An Introduction to Research Use Only (RUO)

In this blog, we recap our eBook, “An Introduction to Research Use Only (RUO)” – Click HERE to download the entire publication.

Learn how it differs from adjacent labels, the FDA and EU guidance, its appropriate use, and the consequences of mislabeling products RUO.

Introduction

In the complex world of medical device development, regulation, and distribution, finding the appropriate label to put on a device may not be simple. When is one label appropriate over another? Does a device need to go through additional testing, verification, or validation? And what are the consequences of using the wrong label? In this eBook, we’ll cover the differences between Research Use Only (RUO) and a medical device – although, it’s generally a very clear distinction.

Using the right language and label is critical to complying with best practices. This is why Regulatory Affairs works with the regulatory bodies to ensure that the limitations of the product are properly documented. In a rush to get products to market, it may be tempting to use a Research Use Only (RUO) label to avoid additional regulatory processes while still empowering other researchers and developers. However, there are risks to using the RUO label inappropriately that can have serious consequences for developers, users, and patients. In fact, mislabeling a product is illegal, and punishable. You can see an example warning letter the FDA sent to Carolina Liquid Chemistries Corp after finding intentional mislabeling in 2019 here.

This introduction will provide an overview of the Research Use Only label, how it differs from similar, adjacent labels, its appropriate use, and the consequences of mislabeling products RUO.

What is Research Use Only (RUO)?

The label Research Use Only (RUO) is generally used to indicate products that are intended for scientific research only. They cannot be used for diagnostic or medical purposes. However, there is no standard definition of “research use only,” and the label has slightly different meanings in the European Union and the United States. With the IVDR regulations, RUO products that are being used in the LDT space are going to be revisited and potentially reclassified as a medical device. With this new classification, teams will likely need to follow design controls, best practices, and industry standards.

What is the FDA guidance on Research Use Only products?

Under the FDA’s guidance issued in 2013 , a product labeled Research Use Only is an In Vitro Diagnostic (IVD) product “that is in the laboratory research phase of development and is being shipped or delivered for an investigation that is not subject to part 812.” The agency includes in this category:

• “Tests that are in development to identify test kit methodology, necessary components, and analytes to be measured.
• “Instrumentation, software, or other electrical/mechanical components under development to determine correct settings, subcomponents, subassemblies, basic operational characteristics, and possible use methods.
• “Reagents under development to determine production methods, purification levels, packaging needs, shelf life, storage conditions, etc.”

The European guidance document MEDDEV 2.14/2 states that a product categorized as an RUO product “must have no intended medical purpose or objective.” The guidance does exempt some tests developed for in-house use as long as the products are not sold to other companies. Some examples of items that can be classified as “research use only” under this exemption include PCR enzymes, gel component agars, and primers.

RELATED: FDA released new draft guidance of premarket submissions for medical devices – are you ready?

What is the difference between ruo and ivd.

An IVD is an “In Vitro Diagnostic Medical Device,” and the general term applies to any device or product that either alone or with other products is intended to be used for diagnostic, monitoring, or compatibility purposes. There are four different regulatory levels for IVDs:

• Research Use Only (RUO)
• General Laboratory Use (GLU)
• For Performance Studies Only (PSO)
• In Vitro Diagnostic Medical Device (IVD)

The simplest explanation for these different levels is that each increasing level requires more testing and oversight. Research Use Only products are at the lowest level of regulation, and In Vitro Diagnostic Medical Devices are at the highest level. Occasionally in the US, products will be labeled as “RUO IVD,” which means an in vitro device that is intended for research use only.

Products labeled with the “CE-IVD” label indicate that they have progressed through the applicable regulatory process and standards (such as IVDD or IVDR). These products are approved for diagnostic use and must include the IVD symbol to be used for medical purposes.

In the EU, as of May 2022, IVDs must comply with Regulation (EU) 2017/746 (IVDR) . The IVDR defines IVDs as follows:

“‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:

(a) concerning a physiological or pathological process or state; (b) concerning congenital physical or mental impairments; (c) concerning the predisposition to a medical condition or a disease; (d) to determine the safety and compatibility with potential recipients; (e) to predict treatment response or reactions; (f) to define or monitoring therapeutic measures.”

All IVDs that comply with the IVDR must carry the CE Mark if marketed in the EU.

Research Use Only products are not subject to regulatory requirements in either the US or the EU, but because they don’t meet the same compliance standards as IVDs, they must be clearly labeled as RUO products and cannot be used for medical purposes.

A known exception is the lab developed test (LDT) pathway for clinical purposes.

What are the requirements for an RUO product?

In the US, RUO products are basically unregulated and do not need to meet any specific requirements to carry the RUO label. The FDA does not specify any restrictions or limitations on RUO products, provided they are clearly labeled “For Research Use Only. Not for use in diagnostic procedures.” For this reason, RUO products can be an excellent solution for laboratories that need research materials for testing and research purposes. Because products with the RUO label do not require extensive testing, verification, and validation, they tend to be more cost-effective for research purposes.

The EU rules are similar. Because RUO products do not have clinical applications, they are not considered medical devices, and there are no requirements for RUO products defined by either the IVDD or the IVDR. These products should not be marked with the IVD mark, and they should be clearly labeled as “Research Use Only.”

RELATED: See how Jama Software ® helped Össur improve the mobility of millions by replacing process rigidity with speed and agility.

Are there alternatives to ruo labels.

Given the significant differences between labeling a product as RUO and labeling a product as IVD, manufacturers and users can’t be too careful when it comes to assigning labels or using products for specific purposes. If there is a risk to using products labeled as RUO, manufacturers and users should opt for products that have attained a higher compliance level. For example, for a doctor’s office or home use, IVD is the right path. For clinical purposes or hospital labs, RUO could be used as LDT as long as they are CAP/CLIA certified, such was the case with COVID-19 testing kits when the pandemic first hit.

For products that meet a higher degree of compliance, it is possible to assign General Laboratory Use (GLU), Performance Studies Only (PSO), or even In Vitro Diagnostic Medical Device (IVD) labels. However, depending on the intended use for the Research Use Only products, pursuing these additional levels of compliance may or may not make sense.

What is CLIA certification?

CLIA stands for Clinical Laboratory Improvement Amendments. The Centers for Medicare & Medicaid Services (CMS) regulates all clinical laboratory testing performed on humans in the United States through CLIA.

What is a CAP accreditation?

CAP stands for The College of American Pathologists (CAP) . The purpose of CAP laboratory accreditation is to ensure laboratories provide precise test results for accurate patient diagnoses, meet CLIA and CAP requirements, and demonstrate compliance with professionally and scientifically sound and approved laboratory operating standards.

What are RUO products used for?

As the name implies, RUO projects should be used for research purposes only. They may be used for basic research, pharmaceutical research, or in-house manufacturing of “home brew kits” for research purposes and potentially for clinical applications via the LDT pathway. RUO products are specifically not to be used to make diagnoses, conduct performance studies, or as a substitute or comparator for a CE-IVD device. They may also not be used for market or feasibility studies. Raw ingredients labeled as RUO products may not be incorporated into a finished IVD product.

Learn more about the advantages and disadvantages of the RUO label (and more) by downloading the entire eBook HERE .

• Recent Posts

• [Webinar Recap] Key Systems Engineering Skills: Critical Thinking and Problem Framing - March 5, 2024
• Jama Connect® Features in Five: Medical Device & Life Sciences Solution 2.0 – Part 2 - July 28, 2023
• Jama Connect® Features in Five: Medical Device & Life Sciences Solution 2.0 – Part 1 - July 21, 2023

USA 135 SW Taylor Suite 200 Portland, Oregon, 97204

EUROPE Amsterdam Queens Tower Delflandlaan 1, 1062EA Amsterdam The Netherlands

© 2024 Jama Software

• JAMA CONNECT
• Product Overview
• Pricing and Licensing
• Success Programs
• Resource Library
• User Community
• Privacy Policy
• Privacy and Security
• Preferences

• Featured News
• Artificial Intelligence
• Bioprocessing
• Drug Discovery
• Genome Editing
• Infectious Diseases
• Translational Medicine
• Browse Issues
• Learning Labs
• eBooks/Perspectives
• GEN Biotechnology
• Re:Gen Open
• New Products
• Conference Calendar
• Get GEN Magazine
• Get GEN eNewsletters

Oversight of Research Use Only Products

By Jeffrey N. Gibbs

March 1, 2010 (Vol. 30, No. 5)

RUO Assays and Instruments Face Greater Scrutiny

The FDA actively regulates medical devices intended for diagnostic use. Diagnostic kits intended for diagnostic use face the full panoply of FDA regulation. In sharp contrast, research use only (RUO) products are essentially unregulated. In fact, although RUO products are often discussed as though they are a kind of medical device, RUOs are not devices at all.

A commercially important class of products, RUOs are defined very briefly by FDA regulations. RUO products are described as products “in the laboratory research phase of development and not represented as an effective in vitro diagnostic product.” This definition has created some uncertainty as to what products fall into the RUO category.

The same regulation establishing the RUO category requires that RUO products bear the following labeling statement: “For Research Use Only—Not for use in diagnostic procedures.” Although not authorized by the regulation, many companies have shortened the statement to just the first clause. FDA regulations do not prescribe any other restrictions or limitations on RUO products beyond this labeling statement. Thus, FDA regulations define the category and prescribe labeling, and nothing more.

Given that RUO products are not intended to diagnose “a disease or other condition,” it is not clear that they are even subject to FDA’s jurisdiction. The intended use of an RUO product—research,  not diagnosis—presumptively removes it from the definition of a device and FDA’s authority.

In any event, aside from bearing the mandated statement, RUO products are not regulated by the agency. For example, they do not need to be listed with FDA or comply with the Quality System Regulation (QSR). They can be sold without any FDA clearance or approval. As a practical matter an RUO is essentially unregulated by FDA.

Over the years, the paramount regulatory issue for products bearing the RUO label has been whether or not they actually do belong within the RUO category. There have been multiple instances in which RUO products have become widely used by laboratories for clinical applications. There have also been a number of occasions where companies have labeled products as RUO but then promoted them for diagnostic use. In some instances, companies have made specific diagnostic claims for their assay or instrument but still labeled the product as RUO.

Biomarker kits are often labeled as RUO because it is not known whether the product has any clinical use or, if so, what that use might be. The assay’s developer may expect that a particular biological substance will be of some clinical value, but not be sure what that value is. Labeling a product RUO, allows it to get into the hands of researchers who can then evaluate whether the product may be potentially valuable for some specific diagnostic purpose.

Often, no clinical use is ever identified. Some assays maintain their true RUO status indefinitely. While the product may be helpful to researchers in understanding basic biological mechanisms, a diagnostic use may never be discovered.

Guidance Documents

FDA has initiated several attempts to try to regulate RUO products more tightly. In the early 1990s, FDA issued a draft Compliance Policy Guide (CPG) document that sought to significantly restrict the availability of RUO products. This guidance document went through several iterations but was never finalized. There is still no guidance document setting out FDA’s policy regarding RUO products, however, reports have recently surfaced that a new RUO policy may finally be released.

One of the elements set forth in the draft CPG was that the distributor of the RUO product should receive a certification from the laboratory customer that the product will be used for research purposes only. Although the CPG was not adopted, some vendors have asked laboratories to sign some type of acknowledgement form. While this will help support a vendor’s position that its product is intended only for research use, it is not currently required. FDA has, however, “encouraged” some instrument suppliers to adopt certification programs. 

Concerned by the proliferation of RUO products, in 1997 FDA tried a different tack. That year, FDA promulgated the Analyte Specific Reagent (ASR) regulation. ASRs were broadly defined as the building blocks of diagnostic assays. Unlike RUOs, ASRs were subject to FDA requirements, including QSRs and Medical Device Reporting. This regulation was prompted, in part, by the belief that it would result in the availability of higher quality materials for laboratory tests and displace some of the lower quality RUOs.

To some degree, that plan succeeded. Many different products were offered to laboratories as ASRs. However, while many of these were basic chemical components, more complex products were also sold as ASRs. Ultimately, FDA concluded that the ASR regulation was being used as a vehicle for  products that didn’t fit the intent of the regulation.

FDA therefore released a guidance document in 2007 that substantially curbed the availability of ASRs by prohibiting companies from combining more than one active component. With the advent of molecular diagnostics, selling a single component was often impracticable, e.g., a primer and probe pair need to be offered together. This narrow interpretation of ASRs has essentially precluded the sale of ASRs for use in molecular diagnostics. Somewhat predictability, a number of companies responded by relabeling their ASRs as RUOs. This has helped lead to a renewed focus on RUOs by FDA.

For years, the principal regulatory question for products labeled as RUOs has been whether they qualify for this classification and hence are not subject to regulation as devices. While FDA has not issued either a regulation or guidance delineating how companies can promote RUOs, the agency has taken enforcement action against a number of RUO companies.

Even absent regulations or guidance, it is apparent that in FDA’s view a product forfeits its RUO status if certain types of claims are made—claims that the product can diagnose a disease or condition, provide clinical sensitivity or specificity data, or offers a clinical benefit. Correspondingly, the instructions for use (IFU) accompanying the product need to be brief.

While the bulk of RUO products have been assays, the RUO category also encompasses instruments and equipment. This can present its own set of regulatory challenges, particularly when an IVD applicant has used an RUO instrument in conjunction with developing its assay, a situation that is now occurring with greater frequency. 

The utilization of RUO instruments in assay development has led to the submission of applications that reference RUO instruments. This may result in naming the RUO instrument in the draft IFU, i.e., the applicant states that the assay is to be performed on an RUO instrument, or the data for the IVD were generated on an RUO instrument.

While FDA had accepted these practices, that has seemingly changed. Therefore, an IVD company that has tested and validated its assay on an RUO instrument or is using RUO assays in its test system should discuss with FDA at an early stage how to address the regulatory implications that may arise from this situation. Simultaneously, companies that are selling RUO-labeled instruments that are being widely used in diagnostics may find that they will be receiving more regulatory scrutiny from FDA.

Over the past few years, RUO products have received relatively little attention from FDA. That regulatory lull seems to be ending.

Jeffrey N. Gibbs ( [email protected] ) is a director at Hyman, Phelps & McNamara. Web: www.hpm.com.

Single-Cell Cloning Remains a Challenge

New approach to nanopore sequencing that is sure to catch your....

• Visit GenomeWeb on Twitter
• Visit GenomeWeb on LinkedIn

Request an Annual Quote

FDA Releases Guidance on Research Use, Investigational Use Only IVDs

NEW YORK (GenomeWeb News) – The Food and Drug Administration has released a guidance document that lays out and clarifies the rules for how in vitro diagnostic products for research use only (RUO) and investigational use only (IUO) may be used, labeled, or marketed.

FDA created the guidance on RUOs and IUOs, which has been in development for several years , because it is concerned that unapproved or uncleared IVDs are being used for clinical diagnostic use, even though their performance characteristics and manufacturing controls have not met the agency's clinical standards.

The agency allows an investigational device exemption (IDE) for medical devices that enables them to be used in research without receiving premarket approval or 510(k) clearance, but a lack of clarity in the exemption has created a loophole that makes it possible for RUOs and IOUs to seep into clinical use.

The worry is that healthcare providers could be misled about the approved applications for RUO and IUO tests, and patients could be harmed. To avoid such harms, FDA wants this guidance to inform IVD makers on how to comply and ensure that devices are being used as they were intended.

The new FDA document covers the appropriate and inappropriate uses for IVDs, as well as requirements for their labeling, manufacturing, and marketing.

To qualify as an IDE, devices must be non-invasive, must not be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic, and must not require an invasive sampling procedure that presents a risk.

The guidance states that RUOs must be labeled, "For Research Use Only. Not for use in Diagnostic Procedures." IUOs must be labeled, "For Investigational Use Only. The performance characteristics of this product have not been established.''

Product labeling alone may not keep IVDs from being marketed for clinical uses, so the guidance provides details regarding how the RUOs and IUOs may be marketed, and the kinds of promotional statements that would conflict with the devices' RUO and IUO status.

Filed under

Mayo clinic launches four-pillar strategy to bring omics into patient care, plasma proteome study finds biomarkers for severe, fatal covid-19, people in the news at illumina, agilent, deepull, sphere fluidics, nucleai, 23andme, new products posted to genomeweb: foundation medicine, cytek biosciences, nimagen, more, in brief this week: ers genomics, lunit, agilent, thermo fisher, congenica, oxford biodynamics, more, roche updates mass spec launch, instrument upgrades, upcoming tests at investor day premium, guardant health colon cancer screening test backed by majority amidst robust debate in fda meeting premium, oxford nanopore eyes tb drug resistance for first in-house-developed diagnostic test premium, cue health shutting down operations, asco publishes guidelines for germline testing in solid tumors.

We use cookies to offer you a better browsing experience and analyse our website performance. We also use third-party cookies to further customise your experience showing relevant content while you are navigating on third-party platforms.

Our Priorities MedTech Europe strives to support our dynamic sector in meeting the needs of patients and health systems. To achieve this, we focus on engaging with healthcare stakeholders on key issues from regulations and market access to digital health and Brexit, among others.

• COVID-19 Information Hub
• Interactions with the Medical Community
• Access to Medical Technology
• Medical Technology Regulations
• Digital Health
• International
• Environmental and Social Sustainability
• Market Data
• Research and Innovation
• Innovative Health Initiative (IHI)

Sector Groups MedTech Europe sector groups bring together company experts to drive forward key healthcare domains, helping to address issues facing these sectors and shaping their future. We have dedicated groups focused on cardiovascular health, ophthalmology, diabetes, orthopaedics, and AMR/HAI.

• Antimicrobial Resistance (AMR) and Healthcare Associated Infections (HAIS)
• Cardiovascular
• Homecare & Community Care
• Orthopaedic

Real stories of people’s lives transformed by medtech.

Your platform for dialogue about medical technologies.

Search on this website

Research Use Only Products

What are Research Use Only (RUO) products? Research Use Only (RUO) products are a distinct category of in vitro diagnostics (IVDs) exclusively tailored for laboratory research. RUOs encompass specialised reagents, equipment, and materials crucial for scientific investigations, contributing significantly to the development of cutting-edge tools and solutions for research applications.

Research Use Only (RUO) products play a crucial role in medical research and innovative management of many patients. These specialised products, which include laboratory reagents and equipment, are exclusively designed for research in controlled laboratory environments. As essential tools for medical and scientific investigations, experimentation, and analysis, RUOs contribute to developing innovative solutions and advancements in medical research.

For example: RUO products can be used for Fundamental Research, in Pharmaceutical Research to find new drug compounds, and for a better identification and quantification of individual chemical substances. In diagnostics research, RUO products are essential to the development of new diagnostic assays and tools.

Unlike in vitro diagnostic medical devices (IVDs), RUOs are dedicated to facilitating research initiatives and are not intended for direct medical procedures with human patients. RUOs are not defined in the EU’s In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR); they are regulated by the EU General Product Safety Regulation and other applicable EU legislations. Manufacturers of RUO products clearly label them as “Research Use Only” and use the RUO label.

From a production and specifications general perspective, the knowledge and processes needed to manufacture RUOs are very similar to those needed to manufacture CE marked IVDs. Many companies which operate in the IVD space will have RUO products in their portfolio. RUOs will generally have a similar chemical and physical composition compared to IVDs, but their intended purpose will be different. While RUO or IVDs might seem similar in their appearance and specifications, unambiguous and documented evidence associating the use of devices with in vitro diagnostic examination procedures is required to qualify a device as an IVD.

RUOs provide researchers and scientists – including those operating in medical laboratories – with valuable resources to advance in the understanding of disease, in drug discovery, in the development of new therapies and diagnostic tools. Laboratories or research consortia often collaborate with RUO manufacturers to tailor products to meet specific research needs and requirements, fostering a collaborative environment and contributing to the continuous evolution of research tools and solutions.

One critical application of RUO is to enable medical laboratories to develop in-house assays to e.g. diagnose rare and emerging conditions or to improve the current knowledge and management of specific diseases for which no adequate CE marked IVDs exist. This not only fulfils a critical and imminent healthcare need but is also a key stepping stone in the eventual development of IVDs. A poignant example of this was the development of COVID-19 assays during the early phase of the pandemic – initially, reference laboratories developed in house assays test for the SARS-CoV-2 virus, and shortly afterwards, commercial IVDs began to reach the market in order to fulfil a critical need during the global health crisis. However, it is worth noting that the use of in-house assays is regulated in IVDR and is subject to certain conditions.

In essence, RUO products provide researchers and physicians with the necessary tools to conduct experiments and studies, contributing to the overall progress in medical research.  Their intended use in laboratory settings supports the development of new technologies and innovative solutions for various research applications.

Share this page

The MedTech Forum 2024

Join the conference on 22-24 May in Vienna

Sign up for your monthly newsletter

By clicking the Subscribe button, you give consent to MedTech Europe AISBL to use of the information you provided and send you content on the services you selected. We will ensure that the information is processed confidentially, and will only share it with third party providers that assist in providing these services. These providers may be located outside the EU; in this case, we will ensure that they are subject to a legal framework adequate in safeguarding your data, in compliance with European data protection law. You can unsubscribe, change your preferences or update your information at any time by clicking on the unsubscribe button available on all messages. For more information on how MedTech Europe will handle your personal data, please refer to our Privacy Policy . You can contact us at [email protected] for further questions related to your privacy and your rights.

Thermo Fisher Scientific

Research Use Only (RUO) Recombinant Antibodies for Biotech and Pharmaceutical Research

Authors: Haripriya Sridharan and Aparna Chandrasekaran

Research use only (RUO) antibodies are used in basic and applied research. Differing fundamentally in their end application from therapeutic or diagnostic antibodies, RUO antibodies are not meant for patient or clinical use; however, they are an essential component in a biotech or pharmaceutical scientist’s toolkit and are used in a myriad of ways during drug or diagnostic development. For example, they are extensively used as research tools to study biological processes and therapeutic targets, such as measuring protein levels after a drug treatment.

Advantages of recombinant monoclonal antibodies

One of the critical considerations for biotech or pharmaceutical research is antibody reproducibility. The traditional choice for monoclonal antibodies were hybridomas derived from the fusion of an antibody producing B cell with a myeloma cell line. However, hybridomas are plagued with challenges such as genetic drift, which can cause a drop in antibody titer over time.

Recombinant antibodies are a new generation of monoclonal antibodies developed in vitro by cloning immunogen-specific antibody genes into expression vectors. Since recombinant antibodies are defined by their sequence, they offer several advantages over traditional hybridomas, such as lot-to-lot reproducibility and the option to use an animal-free production system, in addition to specificity and sensitivity. Furthermore, recombinant antibody expression can be conducted at any scale in a high-throughput manufacturing environment along with a guaranteed long-standing supply of antibody, thus making them an excellent tool for testing multiple samples or for long-term studies.

Due to these advantages, many hybridomas are being converted to recombinant antibodies. During these conversions, the antibody encoding genes from the hybridoma cell lines are cloned into expression vectors. The recombinant antibody has the same antigen binding sequences as the parental hybridoma thereby, retaining the same antigen specificity as the hybridoma. For example, as shown in Figure 1, a rabbit hybridoma encoding an antibody recognizing somatostatin receptor 2 (SSTR2) protein was converted to a rabbit recombinant monoclonal antibody with specificity for SSTR2.

Figure 1:   Recombinant antibody testing data for SSTR2 Recombinant Rabbit Monoclonal Antibody (Cat. No. 704011).

A) HEK-293 cells stably transfected with SSTR2, after 24 hours, cells were treated with 1 µM somatostatin-14 (SRIF) and then fixed and permeabilized. The specimens were incubated with SSTR2 Recombinant Rabbit Monoclonal Antibody (Cat. No. 704011, 1:1000 dilution). Cells were then incubated with Alexa 488-conjugated secondary antibody for 2 hours at room temperature, mounted and examined. Immunofluorescence analysis shows internalization of SST2 receptor from the plasma membrane to perinuclear cluster of the vesicles upon treatment with somatostatin-14 (SRIF – somatotropin release inhibiting factor). Altered expression of the protein upon cell treatment demonstrates antibody specificity.

B) Sections of human neuroendocrine tumor (NET) were dewaxed, microwaved in citric acid and incubated with SSTR2 Recombinant Rabbit Monoclonal Antibody (Cat. No. 704011, 1:1000 dilution). Sections were then sequentially treated with biotinylated anti-rabbit IgG and AB solution. Sections were then developed in DAB and lightly counterstained with hematoxylin.

Recombinant antibodies can be offered in a multitude of formats, including full-length antibodies from a single species or chimeric antibodies, as well as, antibody fragments such as single chain fragment variable (scFv) or antigen-binding fragment (Fab). Each of these formats offers unique benefits that are determined by their end usage and application. In the following sections, we highlight two such examples that were developed to serve distinct research needs.

A GPCR/G-protein complex stabilizing scFv recombinant monoclonal antibody

The scFv16 antibody fragment stabilizes active trimeric G protein complexes by recognizing the interface between G alpha and G beta/gamma subunits and is a valuable tool for CRYO-EM studies of GPCR protein complexes. This scFv is offered as a Recombinant Mouse Monoclonal Antibody (Cat. No. 703976) to serve customers focused on CRYO-EM applications of GPCR protein complexes (Figure 2). The product formulation was specifically developed to ensure compatibility for CRYO-EM applications.

Figure 2: Recombinant antibody testing data for GPCR/G-protein complex-stabilizing scFv Recombinant Mouse Monoclonal Antibody (scFv16) (Cat. No. 703976).

A tagged GPCR was used to pull down a GPCR-heterotrimeric G protein complex that is stabilized by scFv16. A) Size exclusion chromatography (SEC) chromatogram of the purified complex. B) Highlighted sample from SEC was run on SDS-PAGE gel and Coomassie stained. All components of the active complex are present. C) Direct visualization of GPCR-G protein complex by negative stain TEM showing features characteristic for active GPCR complexes that are intact. Data courtesy Dr. David M. Thal, Monash Institute of Pharmaceutical Sciences, Monash University.

Recombinant antibodies for SARS-CoV-2 Spike protein

Sometimes researchers may have specific species requirements for an antibody to ensure compatibility with the rest of the assay or product development process. In these cases, the antigen-binding region (variable regions or the Fab fragment) of the antibody can be fused to the backbone of the required species. Having the same antigen-binding region gives the researcher complete confidence that the antigen-binding specificity is retained. Recombinant antibodies that recognize the spike protein of SARS-CoV-2 were developed as either fully human or human-rabbit chimeric antibodies to serve different research or product development requirements (Figure 3). For example, antibodies with a human constant region are useful as controls for developing kits to detect and characterize immune responses to SARS-CoV-2. At the same time, many laboratories routinely use rabbit antibodies to understand viral biology using immunoassays. Since a key focus area of SARS-CoV-2 research was to study the neutralization of the virus, some of these antibodies were tested and found to neutralize the ACE2-Spike protein interaction (Figure 4), making them useful controls for these experiments. The development of SARS-CoV-2 specific recombinant monoclonal antibodies, including the application and specificity testing, is discussed in further detail in a separate blog ‘Specific and neutralizing recombinant antibodies to SARS-CoV-2’ .

Figure 3: Schematic representation of the SARS-CoV-2 antibody backbones

A) Fully human backbone by grafting onto a human IgG1

B) Human Fab and rabbit Fc chimeric backbone by grafting onto a rabbit IgG.

Figure 4: Spike protein RBD-ACE2 interaction blocking by SARS-CoV-2 Recombinant Monoclonal Antibody (Cat. No. 703973)

ELISA based SARS-CoV-2 inhibitor screening assay shows that the binding of SARS-CoV-2 Spike Protein RBD to human ACE2 was inhibited in the presence of the SARS-CoV-2 Recombinant Monoclonal Antibody (Cat. No. 703973). X-axis represents antibody concentrations and Y-axis represents percent binding signal of human ACE2 to SARS-CoV-2 Spike Protein RBD. The dotted line represents 50% inhibition.

RUO antibodies used in biotech and pharmaceutical research must often fit very specific criteria to maximize their utility as controls or reagents in various workflows. The examples described in this blog highlight how these requirements are being anticipated and met in order to provide optimal antibody performance and reproducibility to support the biotech and pharmaceutical research communities.

Additional Antibody Blogs:

Let’s get ‘specific’ about the TNFR pathway!

DIY Neurons for antibody validation

Translate to Invitrogen antibodies for your ribosomal protein research!

Drivers of the Chromosomal Passenger Complex

PRMTs: Role in epigenetic regulation 

Using Blockers to Unlock Secretory Proteins

Specific and neutralizing recombinant antibodies to SARS-CoV-2

Staining Your Way into Cells: Exploring Cell and Organelle Markers

Is it a T-Cell or B-Cell? Antibodies for Immunophenotyping

December 1, 2021 at 12:50 am

I didn’t know that recombinant monoclonal antibodies have advantages. I will be sure to try them. Maybe they could make a difference.

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

Get news and research reviews on the topic of your choice, right in your inbox.

Subscribe Now

• Select your country/region * Select your country/region United States Canada Afghanistan Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos (Keeling) Islands Colombia Comoros Congo Congo, The Democratic Republic of Cook Islands Costa Rica Cote D'Ivoire Croatia Cuba Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic East Timor Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands (Malvinas) Faroe Islands Fiji Finland Fmr Yugoslav Rep of Macedonia France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guinea Guinea-Bissau Guyana Haiti Heard and McDonald Islands Holy See (Vatican City State) Honduras Hong Kong Hungary Iceland India Indonesia Iran (Islamic Republic Of) Iraq Ireland Israel Italy Jamaica Japan Jordan Kazakstan Kenya Kiribati Korea, Democratic People's Rep Korea, Republic of Kuwait Kyrgyzstan Lao People's Democratic Rep Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macau Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia, Federated States Moldova, Republic of Monaco Mongolia Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands Netherlands Antilles New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Reunion Romania Russian Federation Rwanda Saint Helena Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa Spain Sri Lanka Sth Georgia & Sth Sandwich Is St Vincent and the Grenadines Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan, Province of China Tajikistan Tanzania, United Republic of Thailand Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates United Kingdom Uruguay US Minor Outlying Islands Uzbekistan Vanuatu Venezuela Vietnam Virgin Islands (British) Virgin Islands (U.S.) Wallis and Futuna Islands Western Sahara Yemen Yugoslavia Zambia Zimbabwe
• Pick a category * Pick a category Accelerating Microscopy Advancing Materials Advancing Mining Analyzing Metals Behind the Bench Examining Food Identifying Threats Life in the Lab
• I would like to receive information about content, events, products, services and promotions from Thermo Fisher Scientific and its affiliates. I agree for the Thermo Fisher Scientific group (thermofisher.com/legalentities) to contact me by email and/or telephone to inform me of events, products, services and/or promotions offered in connection with the brands Thermo Scientific™, Applied Biosystems™, Invitrogen™, Gibco™, Ion Torrent ™, Unity Lab Services™, Fisher Scientifc™. I can withdraw my consent and unsubscribe at any time by emailing [email protected] By submitting my data, I give consent to the collection, processing and use of my personal data in accordance with the Thermo Fisher Scientific Policy (thermofisher.com/privacypolicy).
• Comments This field is for validation purposes and should be left unchanged.

• Skip to main content
• Skip to FDA Search
• Skip to in this section menu
• Skip to footer links

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

U.S. Food and Drug Administration

•   Search
•   Menu
• For Industry
• FDA Basics for Industry

What information do I need to import a biological product for research use only?

Biological specimens that are used only for testing in a clinical laboratory or for basic scientific research are not regulated by FDA. These are specimens that are not intended to prevent, treat, diagnose, or cure diseases, injuries, or conditions in humans, so they do not require licensure (i.e., “approval”) by FDA in accordance with Section 351(a) [42 USC 262(a)] of the Public Health Service Act (PHS Act), nor would they likely be a drug or device as defined in sections 201(g) and (h), respectively, of the Federal Food, Drug, and Cosmetic Act [21 USC 321(g) and (h)], nor an HCT/P as defined in 21 CFR 1271.3, under Section 361 of the PHS Act [42 USC 264]. Detailed information about the process for importing biological products into the U.S. is available in questions and answers posted on the web .

Research Use Only or IVD: What’s Right for Your Lab?

by Tina Sobania | Clinical , Molecular

Publish Date: September 13, 2018

There are many misconceptions in the clinical industry regarding laboratory quality control materials. With numerous products available and manufacturers using various labeling practices, how do you know what’s best for your laboratory?

To help clear up the confusion, we’re answering two important questions clinical laboratorians have about quality control products.

Are diagnostic system controls IVDs?

One common misconception is that materials used for quality control of diagnostic systems are not themselves in vitro diagnostics (IVDs).  However, the U.S. Food & Drug Administration (FDA) has written regulations citing quality control material as medical devices. For example, 21 CFR  862.1660 , Mulit-Analyte Controls Unassayed under Clinical Chemistry, and more recently 21 CFR 866.3920 , classify Class II controls requiring FDA 510(k) review under microbiology.

It’s important to understand that if a manufacturer for controls of nucleic acid amplification states its product works with a specific instrument or assay in its labeling or marketing literature, the FDA considers the material to be a Class II IVD and requires a 510(k) review . The FDA has established special controls for this type of material to ensure the product is properly labeled, performs according to claims and remains stable. In addition, IVD material must be manufactured under the FDA’s current Good Manufacturing Practices (cGMP).

Should “Research Use Only” products be used for quality control?

The second misconception clinical laboratories should be aware of involves material labeled as Research Use Only (RUO).  RUO labeling is intended for products that are still under development and are not commercially distributed.  A developer would use this labeling to ship product for “investigation relating to product development” as explained by the FDA in guidance document, Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigation Use Only .

Another factor one must consider is products labeled RUO are not required to be manufactured in accordance with cGMP and FDA Quality System Regulation. Lack of manufacturing controls may be detrimental to the quality of the control material. As such, clinical laboratories using RUO quality control materials to ensure the quality of testing may be placing patients at unnecessary risk.

Key Takeaway

To maintain the highest possible quality of your diagnostic testing, it’s best to choose materials that have been manufactured by a cGMP compliant facility under the FDA QSR, and when necessary reviewed by the FDA.  Materials clearly labeled as IVDs provide that assurance and lower your laboratory’s risk.

Follow the links below to find all the FDA regulations cited in this post.

• 21 CFR 862.1660 CFR – Code of Federal Regulations Title 21, Subchapter H – Medical Devices
• 21 CFR 866.3920 CFR – Code of Federal Regulations Title 21, Subchapter H – Medical Devices
• Distribution of In Vitro Diagnostic Products Labeled for Research Use Only of Investigation Use Only

Written by Tina Sobania

You may also like.

MLS and MLT Career Opportunities

As a manufacturer of quality controls used in clinical diagnostics, we see firsthand the difficulties that laboratory...

The Challenges of Diagnosing and Treating Secondary Infections

In the past two decades, there have been six major global outbreaks of infectious diseases. While these infections may...

Trackbacks/Pingbacks

• Put Your Best Plate Forward – #CreepyCultures is Back! – Microbiologics Blog - […] Read Next – Research Use Only or IVD: What’s Right for Your Lab? […]
• Clinical Case File: Group A Streptococcus – Microbiologics Blog - […] Read Next – Research Use Only or IVD: What’s Right for Your Lab? […]
• Dear Stanley: Molecular QC Best Practices – Microbiologics Blog - […] Read Next – Research Use Only or IVD: What’s Right for Your Lab? […]
• Our Top Posts from 2018 – Microbiologics Blog - […] 1. Research Use Only or IVD: What’s Right for Your Lab? […]
• LDT Oversight Deliberation Continues – Microbiologics Blog - […] Read Next – Research Use Only or IVD: What’s Right for Your Lab? […]

• Pharmaceutical
• Events and Webinars
• Uncategorized

1-800-599-2847 microbiologics.com [email protected]

QUICK LINKS

CATEGORIES RESOURCES ABOUT US CONTACT US SITE MAP PRIVACY POLICY

By using this site you agree to our use of cookies. Please refer to our privacy policy for more information.   Close

Fda guidance on ruo (research use only)/iuo (investigational use only) products.

Instructor: Dev Raheja Product ID: 703898

• Duration: 60 Min

RECORDED TRAINING

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

Why Should You Attend:

FDA is concerned that the distribution of unapproved and uncleared IVD products labeled RUO or IUO, but intended for purposes other than research or investigation (for example, for clinical diagnostic uses), has led, in some cases, to the clinical diagnostic use of products with unproven performance characteristics, and with manufacturing controls that are inadequate to ensure consistent manufacturing of the finished product. Use of such tests for clinical diagnostic purposes may mislead healthcare providers and cause serious adverse health consequences to patients, who are not aware that they are being diagnosed with or treated based on the results of tests with research or investigational products.

This webinar will offer best practices for protecting patients from unauthorized use of RUO and IUO products and conforming to FDA requirements for marketing RUO and IUO products. The course will also highlight distribution practices that are inconsistent with RUO/IUO designations and FDA’s compliance approach among other key discussions.

Learning Objectives:

• Protecting patients from unauthorized use of RUO and IUO products
• Conforming to FDA requirements for marketing RUO and IUO products
• Using adequate practices for RUO and IUO products
• Avoiding manufacturing defects

Areas Covered in the Webinar:

• FDA Requirements for Research Use Only and Investigational Use Only IVD Products
• Research Use Only (RUO) In Vitro Diagnostic Products
• Investigational Use Only (IUO) In Vitro Diagnostic Products
• Appropriate Labeling and Distribution Practices for RUO and IUO Products
• Research Use Only Labeling
• Investigational Use Only Labeling
• Distribution Practices that are Inconsistent with RUO/IUO Designations
• Instructions for Use of an IVD Product Labeled RUO or IUO
• Validation and Verification of Clinical Diagnostic Testing Using IVD Products Labeled RUO or IUO
• Other Relevant Practices
• Use of a Certification Program
• Software Labeled RUO or IUO
• FDA’s Compliance Approach

Who Will Benefit:

• Senior management
• R&D managers and staff
• Pathology staff
• Laboratory personnel
• Production managers
• Clinical staff
• Marketing staff
• Customer support staff
• Regulatory staff
• Quality assurance staff

Instructor Profile:

Dev Raheja, MS,CSP, author of the books Preventing Medical Device Recalls and Safer Hospital Care, is an international risk management, patient safety and quality assurance consultant for medical device, healthcare and aerospace industry for over 25 years. Prior to becoming a consultant in 1982, he worked at GE Healthcare as supervisor of quality assurance/manager of manufacturing engineering, at Cooper Industries as chief engineer, and at Booz-Allen & Hamilton as risk management consultant for a variety of industries.

His clients include Johnson & Johnson, Siemens Medical Systems, Medtronic, Carl Zeiss, Warner-Lambert, Zimmer Holdings, and DuPont. He has served as adjunct professor at the University of Maryland for five years for its PhD program in reliability engineering. He is a Fellow of American Society for Quality and recipient of its Austin Bonis Award for Reliability Education Advancement, former chair of the Reliability Division, and member of the Biomedical Division. He is a senior member of IEEE. Currently, Mr. Raheja serves as an adjunct professor at the Florida Tech for its BBA degree in healthcare management, and has authored two more books - Assurance Technologies Principles and Practices; and Zen and the Art of Breakthrough Quality Management. He has received several industry awards including the Scientific Achievement Award and Educator-of-the Year Award from the System Safety Society. He is a former National Malcolm Baldrige Quality Award Examiner in the first batch of examiners. He serves on the Patient and Families Advisory Council at Johns Hopkins Hospital and is a member of American College of Healthcare Executives.

More Training By Experts

• 3hr Virtual Seminar on Designing Medical Device Software to Prevent Product Recalls
• 4-hr Virtual Seminar: Design Reviews for Efficiency and Efficacy
• Full Day Virtual Seminar: Reliability Engineering Fundamentals for Medical Devices
• Designing Medical Device Alarms to Mitigate New FDA Concerns
• Verification and Validation (V&V) of Software in the Medical Devices

Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective. Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

+1-888-717-2436

[email protected] [email protected] [email protected]

6201 America Center Drive Suite 240, San Jose, CA 95002, USA

PAYMENT METHOD: 100% Secure Transaction

Create a Non-Clinical Research Use Only Certificate Application

January 2024

Table of Contents

Create a non-clinical research use only (ncr) certificate application.

• Section 1 Requestor Information
• Section 2 Manufacturer Information
• Section 3 Product Information
• Section 4 List country(ies) for which the Certificates are requested
• Section 5 Should the country destination be listed on the certificate?
• Section 6 Exporter's Certification Statement

Final Review Screen

Log into the FDA Industry Systems (FIS) https://www.access.fda.gov and select "CDRH Export Certification Application & Tracking System" (CECATS) from the list of systems available on the FURLS "Home" page, as shown in Figure 1 .

Select "Yes" in response to the question "Will the devices be exported from the United States?". Select "Continue" and the system will open the CECATS "Home" page. The CECATS Main Menu page is shown in Figure 2 below.

To create a new application, click "Enter New Application".  All applications that you have saved or submitted will be displayed, as shown in Figure 3 below. Applications that are saved, but not submitted will be in "Draft" status until you submit them.

• To create a new application, click "Enter New Application" from the main Menu page. Select "Enter New Application" again.

• To clone a previous application, click on the double book icon  (Clone icon) associated to the desired application.
• Verify the information on each page is still correct and proceed through each of the sections.

Click "Modify Application" to makes changes to a submitted, but not yet in Under Review status. The following options are available:

• Modify application based on a notification received
• Change the number of certs
• Cancel request

To search using the application number , click Search Application. This option may be used to continue working on a draft application, to clone a previous application, or to make corrections to an application that is in 'Return for Action' status.

NOTE: Return for Action status indicates that upon review of the application by the FDA, additional information or clarification was required. CECATS will send an email to the requestor with comments from the reviewer and will provide a 48-hour window for modifications to be made. If modifications cannot be made within 48 hours, the status will automatically change to "Incomplete". Please clone the application when ready, modify and submit. A new application number will be assigned. No charges are incurred for an application unless certificates are issued.

NOTE: For all applications in a "Draft" status, if you do not perform any activity within 30 days, the status will automatically change to "Not Submitted". Please clone to continue the application.

The Center for Devices and Radiological Health (CDRH) issues several types of Export documents. When creating a new application, select the application type to be requested, as shown in Figure 4 .

Select "Non-Clinical Research Use Only" from the dropdown list.

About NCR Certificates

The NCR Certificate is for the export of a non-clinical research use only product, material, or component that is not intended for human use which may be marketed in, and legally exported from the United States under the Federal Food, Drug, and Cosmetic Act (FD&C). Among the requirements to be met prior to the issuance of this certificate are the following:

• The "Non-Clinical Research Use Only" certificate is for product(s), material(s), or component(s) that are not used to prevent, treat, or diagnose human disease.
• The manufacturing facility is required to label these products according to 21 CFR 809.10(c)(2)(i) or 21 CFR 312.160, as appropriate.
• All products listed on NCR Certificate must be exported from the U.S.
• Each NCR Certificate request must be requested by the U.S. manufacturer. Requests received from a foreign firm will not be considered. A U.S. firm must appear on each NCR Certificate.
• All contract manufacturers and contract sterilizers involved in the manufacturing process must be identified on the 3613c form, regardless of whether or not they will appear on the certificate.

A status bar at the top of every page will track your progress through each step of the application process, as shown in Figure 5 below.

A "Get Help" icon, located at the top right of each page, will provide page specific help. For an overview of all help files available, please refer to the FDA Industry Systems Index of Help Pages at https://www.access.fda.gov/cecats/help/cecats-ncr-guide.html .

Also located the top right corner of each page is a "FURLS HOME" link that will take you to the FURLS "Home" page. The "CECATS HOME" link will take you to the CECATS "Home" page (Refer to Figure 2 ). To log out of the system, select "FURLS HOME" and click on Logout.

At the top and bottom of each screen are navigation buttons, as shown in Figure 6 below.

• Previous – Navigates back one screen or back one step. Information entered on the current screen will NOT be saved if you select the "Previous" button.
• Save & Exit – Information entered up to this point will be saved. Your application will be set to a "Draft" status until you complete and submit the application. If you do not perform any activity for 30 days, the system will automatically change the status to "Not Submitted" and may delete the application. When you log into the CECATS system, all applications in a "Draft" status will be displayed after selecting the "Enter New Application" option from the main menu.
• Save & Continue – Information entered up to this point will be saved in "Draft" status. An application number will be assigned when you click on the "Save & continue" button the first time. This number will be visible on the top of the screen until the application is submitted. Please keep the Application number for your records and for any communications with FDA regarding this application. Your application will be set to a "Draft" status until you complete and submit the application. If you do not perform any activity for 30 days, the system will automatically change the status to "Not Submitted" and may delete the application.
• Next – All information is saved on the current screen and navigates to the beginning of the next step. However, exiting CECATS without using the "Save & Exit" button will cause the loss of the entire request.

NOTE: All Fields are mandatory except those marked as "Optional" in parenthesis. You will NOT be able to proceed to the next step or "Save & Exit" until all mandatory fields have been properly entered on the current screen.

Section 1 - Requestor Information

The system auto-populates specific information from your Online Account Administration (OAA) into section 1 (Requestor Information) of the application. These fields cannot be edited in CECATS.

If the information is incorrect, click the "FURLS Home" link. Then click "Edit Account Profile" on the left-hand side and update your account profile accordingly.

The following two fields are required in section 1:

• Firm Tax ID Code (also referred to as the Employer Identification Number or EIN (a nine-digit numeric value). This number is assigned by the Internal Revenue Service (IRS).

Click "Next". See Figure 7 below.

Figure 7: Section 1 - Requestor Information

On the next screen, you will need to validate your address. NOTE: This address is the requestor's address; It is not used as the facility address on the application or for shipping. Click "Accept validated address and continue" and click "Next" to proceed to Step 2. See Figure 8 below.

Section 2 - Manufacturer Information

 In section 2, you are required to provide information on your manufacturing facility. The system prompts whether you have registered the facility with the FDA via the Device Registration and Listing Module (DRLM), as shown in Figure 9 below.

Facilities Registered in DRLM Flow

If the facility is registered, select "Yes" and click "Next". Enter either the Registration Number or Owner Operator Number (OON), as shown in Figure 10 below.

NOTE: You must enter a valid number in either field. If you cannot provide a valid number, you will not be able to continue with the application process and you must select "Previous" and select "No", as shown in Figure 9 above.

Entering a Registration Number If you enter a (valid) registration number, the facility information including the Firm Name, Address, Registration Number, and Current Status will be displayed as shown in Figure 11 below.

Click "Add". The facility added to the application will be displayed as shown in Figure 12 below.

You have the ability to perform the following:

• Add up to a maximum of three facilities per application by clicking on the "Add Manufacturer" button.
• Remove a facility from the application by clicking the "X" icon (Delete).
• Optional: Update the "Facility Date of Last FDA inspection" by clicking on the Pencil icon associated to a Firm.

Click "Next".

Entering an Owner Operation Number (OON)

As long as the OON is active, a list of all facilities associated with the OON will be displayed. Select one or more facilities (if applicable) from the list of manufacturers that are in active status as shown in Figure 13 . Inactive facilities will be grayed out and cannot be selected.

NOTE: You will only be able to select a facility if the following conditions are met:

• Domestic Address
• Active Status or Active Pending Registration Number Status.

Once you have selected the facility or facilities involved, click "Add".

Facility that has NOT been registered in DRLM Flow

If the facility is not registered, select "No" and click "Next" (Refer to Figure 9 above).

Enter the Manufacturer name and address as shown in Figure 14 below.

Once you have completed entering the facility information, and click "Next" OR If you select "Yes" and click "Next", the system displays the facility added to the application as shown in Figure 15 below.

NOTE: If the manufacturer is the same as the requestor, then you will not have the option to "Edit" any information in this screen as shown in Figure 15 above.

Once you have entered your facility or facilities, click "Next".

Primary Facility: The primary facility is the facility which you represent. The primary facility must be a U.S establishment.

NOTE: By selecting the facility that you represent, CECATS will pre-populate the facility name in the Exporter's Certification Statement which you will sign towards the end of the application.

Once you have selected the Primary Facility, click "Next".

Select the facility/facilities to be displayed on the certificate as shown in Figure 17 below. Click "Next".

NOTE: You must select at least one manufacturer to appear on the certificate.

Section 3 - Product Information

In this section, you will be able to add one or more products to the application.

Prior to selecting the products, identify whether you want to manually enter the products OR to upload your products as shown in Figure 18 below.

Manually Enter Products

If you select "Manually Enter Products", all manufacturers selected in section 2 will be displayed as shown in Figure 19.

Enter the product description and click "Add" as shown in Figure 20 .

Repeat until products have been added for the specified facility. Click "Previous" button to return to the Product Information page as shown in Figure 19 above.

Repeat the steps for adding products for each facility (if applicable). Once you have completed adding products, click on "Next".

NOTE: You must enter at least one product for each facility before continuing to the next step.

Upload Products To upload your product, click on the "product worksheet" hyperlink as shown in Figure 21 to download a template which is in a format that must be used to upload your products.

Type or copy your product list onto the template. Please read the Tips below first.

Tips for uploading products:

Please adhere to the following rules or the system will not accept the upload:

• Rows 1 and 2 must not be deleted. (Product names typed on rows 1 and 2 will not appear on the certificate).
• Do not separate products with any blank rows. CECATS will automatically delete these blank rows on the certificate. Grouping of products can be achieved by entering a dot or dash on the line in between the group. This dot or dash will appear on the certificate.
• Do not exceed the maximum character limit of 150 per cell.
• Once loaded into CECATS, the characters are displayed on certificates in size 8, Arial font.
• There is a single cell available for each product name with CECATS allowing each cell to be up to 150 characters. If you would like the appearance of columns within the one column format, a process called concatenation can be utilized. This can be accomplished using spreadsheet software such as (Microsoft Excel or Libre Office Calc) by concatenating multiple fields into a single field. Information on how to do this in Excel can be found in the Excel help. Basic concatenation instructions are provided below. For additional assistance, please contact FDA at [email protected] .

Concatenation – creating the appearance of multiple columns within a one column format.

For example, a company may store product information in a spreadsheet like this:

Using concatenation functions a company might use a function in another column such as =A2&" - "&B2&" - "&C2 This takes the values found in the cells A2, B2, and C2 and puts them together in a single cell with dashes (which can be changed to any type of separating text desired). The quotes around the dashes indicate that the text (and spaces) between the quotes are actual text to be displayed rather than a reference to a cell or function in the spreadsheet. This is the result of adding the function to cell D2:

Now that the cells with various product information have been concatenated, the concatenated information needs to be moved into a spreadsheet conforming to the CECATS template spreadsheet which is a single cell. Though the concatenation function displays the concatenated text, if this cell is copied to another spreadsheet the result will likely be an error displayed in the cell. This error occurs because the displayed concatenated text is still a function which requires the cells referenced in it to exist in the proper locations. Once the function is moved to a location where those referenced cells no longer exist, the function will not behave as expected. To copy the concatenated text to the CECATS template spreadsheet, copy the text. When pasting the text, the option to only past the values should be used. In Microsoft Excel, the option to only paste the values that are a result of a function is found in the "Paste" or "Paste Special" options. Pasting only values will allow concatenated text to appear correctly in the CECATS template spreadsheet:

Once all of the products have been added to the template and the file is saved, click "Browse…" to navigate to the location of the file. Click "Upload". The product list will be displayed as shown in Figure 22 .

You can add a new device at the beginning of the product list by clicking "Add product". Once you have completed adding/uploading products, click "Next".

Section 4 - List Country(ies) for which the Certificates are requested

Select one or more countries to indicate the destination. Once you have selected the country or countries, select "Next" to proceed as shown in Figure 23 .

NOTE: Another method to select a country (other than scrolling down the list) is to select a country from the country list, then enter the first few letters of the desired country name. The system will jump to the country that begins with the letters entered.

NOTE: The standard format of the electronic certificate will not display an individual country name but will state "foreign countries". To display a specific country on the certificate, select only one country in section 6 AND indicate that country destination should be listed on the certificate in section 8.

Section 5 - Should the country destination be listed on the certificate?

If more than one country was selected in section 4, you will not be able to select "Yes" to display the destination country on the certificate. If you wish to display a specific country on the certificate, you must either go back to section 4 and select only one country or create a new application with the desired country. Otherwise, select "No".

Enter the total number of certificates requested. See Figure 24 below.

Add number of certificates requested, the system will calculate the total fee as shown in Figure 25.

NOTE: The FDA will invoice your firm quarterly for all certificates issued during the quarter.

Section 6 - Exporter's Certification Statement (ECS)

The Exporter's Certification Statement (ECS) acknowledges that you, the responsible official or designee, certify that the facility(s) and the products identified in the "Supplemental Information" are (to the best of your knowledge) in substantial compliance with the FD&C Act and all applicable or pertinent regulations

In this section, the primary facility field will be auto-populated based on the selection you made in section 2. Select "I Agree" at the bottom of this section and enter your name and title. You will not be able to continue with the application until these fields have been completed See Figure 26 below:

Click " Next " to proceed to the Final Review Page.

The entire application broken out by section will be displayed as shown in Figure 27 below. You may choose to modify a section by selecting "Edit" next to the section to be updated. The data entered in the chosen section will be displayed and changes may be made as needed.

Figure 27: Final Review Page

PREVIEW THE CERTIFICATE!!! To ensure that the facility name and address is appropriate, and that the headers, product list and groupings appear as preferred, click "Preview Certificate". If any changes are required, return to the appropriate section and update prior to continuing onto Section 6.

NOTE: The order of the facilities on the final certificates may not be the same as the sample.

NOTE: Your submission is not complete until you click "Submit".

Print Application:  You may choose to print your application prior to submission using the "Print" button at the bottom of the page. However, unless you have previously saved the application, the application number will not appear on the printed application.  There will another opportunity to print the application after it is submitted and an application number has been assigned.

Submission:  When your application is ready for submission, click "Submit".  A message that your application was successfully submitted will appear as shown in Figure 28 below. An application number will be displayed and the opportunity to print a copy of the application is available. **Please save the application number for future reference. The application number will be required to check the status of your application. You will also receive an email confirmation that your application has been successfully received along with the application number.

• Collections
• Recent Additions
• Coming Soon
• Content and Copyright
• Public Access Policy
• home CDC Stacks

Research use only 2019-novel coronavirus (2019-nCoV) real-time RT-PCR primers and probes

Search our Collections & Repository

• Advanced Search
• Custom Query

All these words:

For very narrow results

This exact word or phrase:

When looking for a specific result

Any of these words:

Best used for discovery & interchangable words

None of these words:

Recommended to be used in conjunction with other fields

Publication Date Range:

Document Type:

Collection:

Query Builder

For additional assistance using the Custom Query please check out our Help Page

May 29, 2020

• By Centers for Disease Control and Prevention (U.S.)
• Corporate Authors: Centers for Disease Control and Prevention (U.S.)
• Description: Disclaimer: These sequences are intended to be used for the purposes of respiratory virus surveillance and research. The recipient agrees to use them in compliance with all applicable laws and regulations. Every effort has been made to assure the accuracy of the sequences, but CDC cannot provide any warranty regarding their accuracy. The recipient can acknowledge the source of sequences in any oral presentations or written publications concerning the research project by referring to the Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA. Last Updated: May 29, 2020 rt-pcr-panel-primer-probes.pdf More ▼ -->
• Subjects: [+] Clinical Laboratory Techniques Coronavirus Infections/diagnosis COVID-19 Nucleic Acid Testing DNA Primers Real-Time Polymerase Chain Reaction
• Document Type: Pamphlet (or booklet)
• Collection(s): Stephen B. Thacker CDC Library collection
• Main Document Checksum: [+] urn:sha256:b212c6778216d0a52f9c27151f204e2dd8af974ad75d5d3e7cb3b99ef3bb25cf
• Download URL: https://stacks.cdc.gov/view/cdc/88834/cdc_88834_DS1.pdf

Supporting Files

You may also like.

Checkout today's featured content at stacks.cdc.gov

Exit Notification/Disclaimer Policy

• The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website.
• Linking to a non-federal Website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website.
• You will be subject to the destination website's privacy policy when you follow the link.
• CDC is not responsible for Section 508 compliance (accessibility) on other federal or private websites.

Have Questions?

Call 800-232-4636

CDC INFORMATION

• File Viewers & Players
• Other Languages
• No Fear Act
• Nondiscrimination
• Accessibility
• Vulnerability Disclosure Policy

CONNECT WITH CDC

• Search Menu
• Sign in through your institution
• Advance articles
• Author Interviews
• Research Curations
• Author Guidelines
• Open Access
• Submission Site
• Why Submit?
• About Journal of Consumer Research
• Editorial Board
• Advertising and Corporate Services
• Self-Archiving Policy
• Dispatch Dates
• Journals on Oxford Academic
• Books on Oxford Academic

Are ‘10-Grams of Protein” Better than ’Ten Grams of Protein”? How Digits versus Number Words Influence Consumer Judgments

• Article contents
• Figures & tables
• Supplementary Data

Marisabel Romero, Adam W Craig, Milica Mormann, Anand Kumar, Are ‘10-Grams of Protein” Better than ’Ten Grams of Protein”? How Digits versus Number Words Influence Consumer Judgments, Journal of Consumer Research , 2024;, ucae030, https://doi.org/10.1093/jcr/ucae030

• Permissions Icon Permissions

Numerical information can be communicated using different number formats, such as digits (“5”) or number words (“five”). For example, a battery product may claim to last for “5 hours” or “five hours.” And while these two formats are used interchangeably in the marketplace, it is not clear how they influence consumer judgments and behavior. Via six experimental studies, two online ad campaigns, and one large secondary dataset analysis, we find that digits, compared to number words, positively affect consumer behavior. We refer to this phenomenon as the number format effect . We further show that the number format effect occurs because consumers feel that digits (vs. number words) are the right way to present numerical information: digits lead to a sense of feeling right that then affects consumer behavior. Finally, we show that the number format effect is amplified when credibility of the source of information is low, and attenuated when source credibility is high. The current research advances knowledge of how numerical information influences consumer judgments and behavior and carries important implications for marketers and policymakers as they communicate numerical information to consumers.

Email alerts

Citing articles via.

• Recommend to your Library

Affiliations

• Online ISSN 1537-5277
• Print ISSN 0093-5301
• Copyright © 2024 Journal of Consumer Research Inc.
• About Oxford Academic
• Publish journals with us
• University press partners
• What we publish
• New features  
• Open access
• Institutional account management
• Rights and permissions
• Get help with access
• Accessibility
• Advertising
• Media enquiries
• Oxford University Press
• Oxford Languages
• University of Oxford

Oxford University Press is a department of the University of Oxford. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide

• Copyright © 2024 Oxford University Press
• Cookie settings
• Cookie policy
• Privacy policy
• Legal notice

This Feature Is Available To Subscribers Only

Sign In or Create an Account

This PDF is available to Subscribers Only

For full access to this pdf, sign in to an existing account, or purchase an annual subscription.

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

• View all journals
• Explore content
• About the journal
• Publish with us
• Sign up for alerts
• 12 May 2024

Is the Internet bad for you? Huge study reveals surprise effect on well-being

• Carissa Wong

You can also search for this author in PubMed   Google Scholar

A global, 16-year study 1 of 2.4 million people has found that Internet use might boost measures of well-being, such as life satisfaction and sense of purpose — challenging the commonly held idea that Internet use has negative effects on people’s welfare.

Access options

Access Nature and 54 other Nature Portfolio journals

Get Nature+, our best-value online-access subscription

24,99 € / 30 days

cancel any time

Subscribe to this journal

Receive 51 print issues and online access

185,98 € per year

only 3,65 € per issue

Rent or buy this article

Prices vary by article type

Prices may be subject to local taxes which are calculated during checkout

doi: https://doi.org/10.1038/d41586-024-01410-z

Vuorre, M. & Przybylski, A. K. Technol. Mind Behav . https://doi.org/10.1037/tmb0000127 (2024).

Article   Google Scholar  

Heffer, T. et al. Clin. Psychol. Sci. 7 , 462–470 (2018).

Coyne, S. M., Rogers, A. A., Zurcher, J. D., Stockdale, L. & Booth, M. Comput. Hum. Behav . 104 , 106160 (2020).

Download references

Reprints and permissions

Related Articles

• Public health

Why role-playing games can spur climate action

World View 22 MAY 24

How does ChatGPT ‘think’? Psychology and neuroscience crack open AI large language models

News Feature 14 MAY 24

Daniel Kahneman obituary: psychologist who revolutionized the way we think about thinking

Obituary 03 MAY 24

Ozempic keeps wowing: trial data show benefits for kidney disease

News 24 MAY 24

Trials that infected people with common colds can inform today’s COVID-19 challenge trials

Correspondence 21 MAY 24

A global pandemic treaty is in sight: don’t scupper it

Editorial 21 MAY 24

Can mathematicians help to solve social-justice problems?

Career Feature 22 MAY 24

Internet use and teen mental health: it’s about more than just screen time

Professor, Division Director, Translational and Clinical Pharmacology

Cincinnati Children’s seeks a director of the Division of Translational and Clinical Pharmacology.

Cincinnati, Ohio

Cincinnati Children's Hospital & Medical Center

Data Analyst for Gene Regulation as an Academic Functional Specialist

The Rheinische Friedrich-Wilhelms-Universität Bonn is an international research university with a broad spectrum of subjects. With 200 years of his...

53113, Bonn (DE)

Rheinische Friedrich-Wilhelms-Universität

Recruitment of Global Talent at the Institute of Zoology, Chinese Academy of Sciences (IOZ, CAS)

The Institute of Zoology (IOZ), Chinese Academy of Sciences (CAS), is seeking global talents around the world.

Beijing, China

Institute of Zoology, Chinese Academy of Sciences (IOZ, CAS)

Full Professorship (W3) in “Organic Environmental Geochemistry (f/m/d)

The Institute of Earth Sciences within the Faculty of Chemistry and Earth Sciences at Heidelberg University invites applications for a   FULL PROFE...

Heidelberg, Brandenburg (DE)

Universität Heidelberg

Postdoctoral scholarship in Structural biology of neurodegeneration

A 2-year fellowship in multidisciplinary project combining molecular, structural and cell biology approaches to understand neurodegenerative disease

Umeå, Sweden

Umeå University

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Quick links

• Explore articles by subject
• Guide to authors
• Editorial policies

Numbers, Facts and Trends Shaping Your World

Read our research on:

Full Topic List

Regions & Countries

• Publications
• Our Methods
• Short Reads
• Tools & Resources

Read Our Research On:

Is College Worth It?

As economic outcomes for young adults with and without degrees have improved, americans hold mixed views on the value of college, table of contents.

• Labor force trends and economic outcomes for young adults
• Economic outcomes for young men
• Economic outcomes for young women
• Wealth trends for households headed by a young adult
• The importance of a four-year college degree
• Getting a high-paying job without a college degree
• Do Americans think their education prepared them for the workplace?
• Is college worth the cost?
• Acknowledgments
• The American Trends Panel survey methodology
• Current Population Survey methodology
• Survey of Consumer Finances methodology

Pew Research Center conducted this study to better understand public views on the importance of a four-year college degree. The study also explores key trends in the economic outcomes of young adults among those who have and have not completed a four-year college degree.

The analysis in this report is based on three data sources. The labor force, earnings, hours, household income and poverty characteristics come from the U.S. Census Bureau’s Annual Social and Economic Supplement of the Current Population Survey. The findings on net worth are based on the Federal Reserve’s Survey of Consumer Finances.

The data on public views on the value of a college degree was collected as part of a Center survey of 5,203 U.S. adults conducted Nov. 27 to Dec. 3, 2023. Everyone who took part in the survey is a member of Pew Research Center’s American Trends Panel (ATP), an online survey panel that is recruited through national, random sampling of residential addresses. Address-based sampling ensures that nearly all U.S. adults have a chance of selection. The survey is weighted to be representative of the U.S. adult population by gender, race, ethnicity, partisan affiliation, education and other categories. Read more about the ATP’s methodology .

Here are the questions used for this report , along with responses, and the survey’s methodology .

Young adults refers to Americans ages 25 to 34.

Noncollege adults include those who have some college education as well as those who graduated from high school but did not attend college. Adults who have not completed high school are not included in the analysis of noncollege adults. About 6% of young adults have not completed high school. Trends in some labor market outcomes for those who have not finished high school are impacted by changes in the foreign-born share of the U.S. population. The Census data used in this analysis did not collect information on nativity before 1994.

Some college includes those with an associate degree and those who attended college but did not obtain a degree.

The some college or less population refers to adults who have some college education, those with a high school diploma only and those who did not graduate high school.

A full-time, full-year worker works at least 50 weeks per year and usually 35 hours a week or more.

The labor force includes all who are employed and those who are unemployed but looking for work.

The labor force participation rate is the share of a population that is in the labor force.

Young adults living independently refers to those who are not living in the home of either of their parents.

Household income is the sum of incomes received by all members of the household ages 15 and older. Income is the sum of earnings from work, capital income such as interest and dividends, rental income, retirement income, and transfer income (such as government assistance) before payments for such things as personal income taxes, Social Security and Medicare taxes, union dues, etc. Non-cash transfers such as food stamps, health benefits, subsidized housing and energy assistance are not included. As household income is pretax, it does not include stimulus payments or tax credits for earned income and children/dependent care.

Net worth, or wealth, is the difference between the value of what a household owns (assets) and what it owes (debts).

All references to party affiliation include those who lean toward that party. Republicans include those who identify as Republicans and those who say they lean toward the Republican Party. Democrats include those who identify as Democrats and those who say they lean toward the Democratic Party.

At a time when many Americans are questioning the value of a four-year college degree, economic outcomes for young adults without a degree are improving.

After decades of falling wages, young U.S. workers (ages 25 to 34) without a bachelor’s degree have seen their earnings increase over the past 10 years. Their overall wealth has gone up too, and fewer are living in poverty today.

Things have also improved for young college graduates over this period. As a result, the gap in earnings between young adults with and without a college degree has not narrowed.

The public has mixed views on the importance of having a college degree, and many have doubts about whether the cost is worth it, according to a new Pew Research Center survey.

• Only one-in-four U.S. adults say it’s extremely or very important to have a four-year college degree in order to get a well-paying job in today’s economy. About a third (35%) say a college degree is somewhat important, while 40% say it’s not too or not at all important.
• Roughly half (49%) say it’s less important to have a four-year college degree today in order to get a well-paying job than it was 20 years ago; 32% say it’s more important, and 17% say it’s about as important as it was 20 years ago.
• Only 22% say the cost of getting a four-year college degree today is worth it even if someone has to take out loans. Some 47% say the cost is worth it only if someone doesn’t have to take out loans. And 29% say the cost is not worth it.

These findings come amid rising tuition costs and mounting student debt . Views on the cost of college differ by Americans’ level of education. But even among four-year college graduates, only about a third (32%) say college is worth the cost even if someone has to take out loans – though they are more likely than those without a degree to say this.

Four-year college graduates (58%) are much more likely than those without a college degree (26%) to say their education was extremely or very useful in giving them the skills and knowledge they needed to get a well-paying job. (This finding excludes the 9% of respondents who said this question did not apply to them.)

Views on the importance of college differ widely by partisanship. Republicans and Republican-leaning independents are more likely than Democrats and Democratic leaners to say:

• It’s not too or not at all important to have a four-year college degree in order to get a well-paying job (50% of Republicans vs. 30% of Democrats)
• A college degree is less important now than it was 20 years ago (57% vs. 43%)
• It’s extremely or very likely someone without a four-year college degree can get a well-paying job (42% vs. 26%)

At the same time that the public is expressing doubts about the value of college, a new Center analysis of government data finds young adults without a college degree are doing better on some key measures than they have in recent years.

A narrow majority of workers ages 25 to 34 do not have a four-year college degree (54% in 2023). Earnings for these young workers mostly trended downward from the mid-1970s until roughly a decade ago.

Outcomes have been especially poor for young men without a college degree. Other research has shown that this group saw falling labor force participation and sagging earnings starting in the early 1970s , but the last decade has marked a turning point.

This analysis looks at young men and young women separately because of their different experiences in the labor force.

Trends for young men

• Labor force participation: The share of young men without a college degree who were working or looking for work dropped steadily from 1970 until about 2014. Our new analysis suggests things have stabilized somewhat for this group over the past decade. Meanwhile, labor force participation among young men with a four-year degree has remained mostly flat.
• Full-time, full-year employment: The share of employed young men without a college degree who are working full time and year-round has varied somewhat over the years – trending downward during recessions. It’s risen significantly since the Great Recession of 2007-09, with the exception of a sharp dip in 2021 due to the COVID-19 pandemic. For employed young men with a college degree, the share working full time, full year has remained more stable over the years.

• Median annual earnings: Since 2014, earnings have risen for young men with some college education and for those whose highest attainment is a high school diploma. Even so, earnings for these groups remain below where they were in the early 1970s. Earnings for young men with a bachelor’s degree have also trended up, for the most part, over the past 10 years.
• Poverty: Among young men without a college degree who are living independently from their parents, the share in poverty has fallen significantly over the last decade. For example, 12% of young men with a high school diploma were living in poverty in 2023, down from a peak of 17% in 2011. The share of young men with a four-year college degree who are in poverty has also fallen and remains below that of noncollege young men.

Trends for young women

• Labor force participation: The shares of young women with and without a college degree in the labor force grew steadily from 1970 to about 1990. Among those without a college degree, the share fell after 2000, and the drop-off was especially sharp for young women with a high school diploma. Since 2014, labor force participation for both groups of young women has increased.
• Full-time, full-year employment: The shares of employed young women working full time and year-round, regardless of their educational attainment, have steadily increased over the decades. There was a decline during and after the Great Recession and again (briefly) in 2021 due to the pandemic. Today, the shares of women working full time, full year are the highest they’ve ever been across education levels.

• Median annual earnings: Median earnings for young women without a college degree were relatively flat from 1970 until about a decade ago. These women did not experience the steady decline in earnings that noncollege young men did over this period. By contrast, earnings have grown over the decades for young women with a college degree. In the past 10 years, earnings for women both with and without a college degree have risen.
• Poverty: As is the case for young men without a college degree, the share of noncollege young women living in poverty has fallen substantially over the past decade. In 2014, 31% of women with a high school diploma who lived independently from their parents were in poverty. By 2023, that share had fallen to 21%. Young women with a college degree remain much less likely to be in poverty than their counterparts with less education.

Sign up for our weekly newsletter

Fresh data delivery Saturday mornings

Sign up for The Briefing

Weekly updates on the world of news & information

• Business & Workplace
• Economic Conditions
• Higher Education
• Income & Wages
• Recessions & Recoveries
• Student Loans

Half of Latinas Say Hispanic Women’s Situation Has Improved in the Past Decade and Expect More Gains

From businesses and banks to colleges and churches: americans’ views of u.s. institutions, fewer young men are in college, especially at 4-year schools, key facts about u.s. latinos with graduate degrees, private, selective colleges are most likely to use race, ethnicity as a factor in admissions decisions, most popular, report materials.

1615 L St. NW, Suite 800 Washington, DC 20036 USA (+1) 202-419-4300 | Main (+1) 202-857-8562 | Fax (+1) 202-419-4372 |  Media Inquiries

Research Topics

• Email Newsletters

ABOUT PEW RESEARCH CENTER  Pew Research Center is a nonpartisan fact tank that informs the public about the issues, attitudes and trends shaping the world. It conducts public opinion polling, demographic research, media content analysis and other empirical social science research. Pew Research Center does not take policy positions. It is a subsidiary of  The Pew Charitable Trusts .

Copyright 2024 Pew Research Center

Teens who use marijuana are more likely to suffer psychotic disorders, study finds

Teenagers who used cannabis within the last year had a dramatically higher rate of developing a psychotic disorder, according to a study published Wednesday. 

The study, led by researchers from the University of Toronto, found an 11 times higher risk of developing a psychotic disorder among teenagers who used cannabis compared with those who did not. When the analysis was limited to just emergency room visits and hospitalizations, there was a 27-fold increase in psychotic disorders in teenagers who had used the drug. 

“When I see youths with psychotic symptoms, they’re almost always using lots of cannabis,” said Dr. Leslie Hulvershorn, a child psychiatrist and chair of the psychiatry department at Indiana University who was not involved with the study. “It would be unusual to see someone present with psychotic symptoms to a hospital and not have smoked cannabis.”

The paper adds to the growing body of research that links cannabis to an increased risk of psychotic disorders, particularly in adolescence. Use of marijuana, particularly higher-potency products, has been linked to a variety of mental health disorders, including schizophrenia, anxiety and depression .

“I think that there’s enough evidence out there for us to give recommendations that teens probably shouldn’t be using cannabis,” said the study’s lead author, Andre McDonald, a postdoctoral research fellow at McMaster University in Hamilton, Ontario. “If we can somehow ask teens to delay their use until their brain has developed a little further, I think that would be good for public health.”

While most teenagers who use cannabis will not develop psychotic disorders, McDonald said, the findings are concerning given how debilitating these conditions can be. 

The new study, like previous research on marijuana and psychosis, does not directly prove that marijuana is causing psychotic disorders. While it’s possible that teens who were prone to develop psychotic disorders could have also been more likely to use cannabis, it’s unlikely because of how striking the association was, Hulvershorn said. 

“The magnitude of the effect here is just hard to believe that it’s not related to cannabis,” Hulvershorn said. 

There was no association between cannabis use and psychotic disorders in people ages 20 to 33. 

“There’s something about that stage of brain development that we haven’t yet fully characterized — where there’s a window of time where cannabis use may increase the risk of psychosis,” said Dr. Kevin Gray, a professor of psychiatry and director of addiction sciences at the Medical University of South Carolina who was not involved with the study. “This study really puts a fine point on delaying cannabis use until your 20s may mitigate one of the most potentially serious risks.”

The Biden administration has been moving toward rescheduling marijuana from Schedule I to the less dangerous Schedule III, which would also acknowledge its medical benefits at the federal level. While the potential change is expected later this year, cannabis is currently legal in 24 states for recreational use.

Marijuana use among high school students has remained steady in recent years. Nearly 1 in 3 12th graders reported using it in the previous year, according to the 2023 Monitoring the Future Survey, an annual survey that measures drug and alcohol use among adolescent students nationwide. 

The new research, published in the respected journal Psychological Medicine, includes data from over 11,000 teens and young adults who were ages 12 to 24 at the beginning of the study.

The authors pulled from the annual Canadian Community Health Survey, focusing on 2009 to 2012. Participants were then followed for up to nine years after the initial survey to track any visits they may have had to doctors or emergency rooms or any times they were admitted to hospitals.. 

Of the teens who were hospitalized or visited emergency rooms for psychotic disorders, roughly 5 in 6 had reported previous cannabis use.

“We see this replicated over and over again that there’s this developmental window of adolescence that’s very high-risk,” Gray said. 

It’s not completely clear why, he added, but one theory is that disruptions to the endocannabinoid system in adolescence may make psychotic symptoms more likely. The endocannabinoid system is a complex signaling system in the brain that marijuana targets. That could make it harder to distinguish reality from what is going on inside the head, leading to symptoms such as hallucinations. 

The authors did not specifically look at how the potency of marijuana products affected the risk of mental disorders, although previous research has found an increased risk .

Akshay Syal, M.D., is a medical fellow with the NBC News Health and Medical Unit. 

IU’s cloud computing resource receives $4.9M to expand AI access for research

Jetsteam2 awarded supplemental NSF grant to join National AI Research Resource Pilot

Indiana University’s Jetsteam2 cloud computing resource will be one of the first of the National Science Foundation’s advanced computing platforms to support projects enabled by the National Artificial Intelligence Research Resource Pilot program .

As part of this program, the Jetstream2 project will receive nearly $4.9 million to expand the resource. The grant, which was awarded as a supplement to IU’s Jetstream2 funding , brings the total award value for the project to nearly $29.4 million.

The NAIRR Pilot program — the result of President Joe Biden’s Executive Order on the Safe, Secure and Trustworthy Development and Use of AI — aims to provide AI researchers and students access to key AI resources and data. The first 35 projects of the NAIRR Pilot program will be supported with computational time and mark a significant milestone in fostering responsible AI research across the nation.

“The NAIRR Pilot, fueled by the need to advance responsible AI research and broaden access to cutting-edge resources needed for AI research, symbolizes a firm stride towards democratizing access to vital AI tools across the talented communities in all corners of our country,” NSF Director Sethuraman Panchanathan said. “While this is only the first step in our NAIRR efforts, we plan to rapidly expand our partnerships and secure the level of investments needed to realize the NAIRR vision and unlock the full potential of AI for the benefit of humanity and society.”

David Hancock, director of advanced cyberinfrastructure at IU, said this pilot program presents a unique opportunity to gain new experiences with researchers and create lasting relationships.

“We all benefit and learn from this kind of experience,” he said. “We hope to provide meaningful resources that positively impact researchers and educators, highlighting the scientific and educational uses of AI and supercomputers down the road.”

Since 2016, the Jetstream system has given thousands of U.S. researchers access to a powerful cloud-based environment that complements other NSF systems — all from a laptop or tablet — allowing them to explore and understand immense amounts of data. Supporting computation, experimentation and teaching, Jetstream has benefited researchers from a wide range of fields by focusing on usability and support.

The Jetstream2 project is led by Research Technologies, a division of University Information Technology Services and a center in the Pervasive Technology Institute at IU.

Jetstream2’s primary cloud is at IU Bloomington, with regional clouds at Arizona State University, the Cornell University Center for Advanced Computing, University of Hawaiʻi and the Texas Advanced Computing Center in Austin, Texas. Jetstream2 also has partnerships with the University of Arizona, Johns Hopkins University and University Corporation for Atmospheric Research.

Filed under:

More stories.

IU researchers using high-performance computing to improve cancer treatment

Q&A with artist Nanette Vonnegut, daughter of Hoosier author

Social media.

• Facebook for IU
• Linkedin for IU
• Twitter for IU
• Instagram for IU
• Youtube for IU

Additional resources

Indiana university.

• About Email at IU
• People Directory
• Non-discrimination Notice
• Email Newsletters & Press Releases