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  1. MCM Legal, Regulatory and Policy Framework

Information for Laboratories Implementing IVD Tests Under EUA

One way FDA helps enable access to medical countermeasures (MCMs), such as in vitro diagnostic (IVD) tests, is through Emergency Use Authorizations (EUAs). An EUA allows FDA to authorize use of an unapproved MCM, in anticipation of a potential emergency or during an actual emergency involving a chemical, biological, radiological, or nuclear agent, or emerging infectious disease, if criteria in section 564 of the Federal Food, Drug, and Cosmetic Act are met.

COVID-19 response update (November 15, 2021): FDA Updates Test Policies to Help to Ensure Accuracy and Reliability of Tests and Increase Access to At-Home Tests - FDA is taking several important actions to support ongoing nationwide COVID-19 testing efforts. These actions are aimed at further increasing access to accurate and reliable COVID-19 tests, particularly diagnostic tests that can be performed at home or in places like doctor’s offices, hospitals, urgent care centers and emergency rooms without having to be sent to a central lab for testing. Also see: Statement by HHS Secretary Xavier Becerra on Withdrawal of HHS Policy on Laboratory-Developed Tests and Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) 

Moving forward, the FDA generally intends to focus its review on EUA requests for the following types of tests:  

  • At-home and point-of-care (POC) diagnostic tests for use with or without a prescription and that can be manufactured in high volumes;
  • Certain high-volume, lab-based molecular diagnostic tests (and home collection kits for use with such tests) that expand testing capacity or accessibility such as through pooling of specimens to increase throughput, testing specimens collected at home and shipped to the lab, screening asymptomatic individuals or detecting multiple different respiratory viruses at once;
  • Certain lab-based and POC high volume antibody tests that can measure the amount of antibodies (fully quantitative antibody tests) or the amount of neutralizing antibodies; and 
  • Tests for which the request is from, or supported by, a U.S. government stakeholder, such as the Biomedical Advanced Research and Development Authority or the National Institutes of Health’s Rapid Acceleration of Diagnostics.

Developers of other tests may consider pursuing marketing authorization through traditional device review pathways such as 510(k) notification or De Novo classification. 

This page is intended for laboratories that are implementing in vitro diagnostic assays (tests) under an EUA and will help laboratories using tests available under EUA learn more about the benefits and limitations of EUA tests, and answer frequently asked questions, including how to report problems with an EUA test to FDA during an emergency. Also see: Emergency Use Authorizations for Medical Devices

On this page:

Considerations When Choosing an IVD Test

Patients, as well as their physicians, depend on FDA to ensure that the tests they use to make medical decisions are accurate, reliable, and clinically meaningful.
FDA requirements for many IVDs intended for clinical diagnostic use include premarket review through one of the following pathways:

  • Premarket Approval (PMA)
  • Premarket Notification (510(k)), or
  • De Novo Classification 

Under certain emergency circumstances (as described in an HHS EUA declaration), FDA can enable access to an IVD based on less data (e.g., abbreviated analytical and clinical validation) than would be needed for a PMA, 510(k) or De novo, under an emergency access mechanism called an EUA, provided certain criteria are met: 

  • the chemical, biological, radiological, or nuclear agent, including an emergent infectious disease, can cause a serious or life-threatening disease or condition;
  • based on the totality of scientific evidence, it is reasonable to believe that the IVD may be effective in diagnosing the disease or condition;
  • the known and potential benefits of the use of the IVD outweigh its known and potential risks; and
  • there is no adequate, approved, and available alternative.  (Note:  FDA cannot issue an EUA for use of an IVD if there is available an adequate IVD legally marketed under a PMA, 510(k), or De novo).

Search FDA Device Databases

FDA offers a variety of Medical Device Databases to help you find an appropriate test:

Hints for searching FDA databases

When searching the FDA databases for device products it can be helpful to know the product code of the device or group of devices. Alternatively, typing the pathogen name, e.g. Dengue or DENV, under the device/device name section can be helpful in identifying devices.

Additional information

To help laboratories decide which Zika IVD EUA test they may want to implement, FDA provides the following tables of key characteristics, performance characteristics, and instruments/methods:

Implementing a Test:  Getting Started

Important information for laboratories with regard to a specific IVD authorized for use under an EUA can be found in the EUA Authorization Letters.  Since 2018, FDA has also been copying relevant information from the Authorization Letter in a section of the Instructions for Use entitled, “Conditions for Authorization for the Laboratory” that outline laboratory responsibilities when implementing an EUA IVD.

The Centers for Medicare and Medicaid Services published a memo to their surveyors explaining policy related to the Clinical Laboratory Improvement Amendments (CLIA) regulations as they apply to assays used under EUA. This memo discusses laboratory compliance with CLIA regulations and the verification of performance specifications for EUA IVD assays.

Tri-Agency Task Force for Emergency Diagnostics (TTFED)

The Tri-Agency Task Force for Emergency Diagnostics (TTFED) with members from Centers for Disease Control and Prevention (CDC), FDA, and Centers for Medicare and Medicaid Services (CMS) was established to develop a process to collaborate on future emergency diagnostic response needs. In advance of an emergency, the TTFED will work to define, refine, and streamline interagency approaches for the implementation of Emergency Use Authorization (EUA) in vitro diagnostic (IVD) assays. During an emergency, the TTFED will provide a forum for discussion of agent- or response-specific EUA IVD assays to help facilitate rapid implementation of the assays in the U.S. healthcare system. The TTFED Charter outlining the task force scope of activities was signed in 2019 and is publicly available. Agency-specific actions and matters will continue to fall under each member agency’s respective statutory authorities. The TTFED will in no way involve itself in decision-making that is under the jurisdiction of a member agency.

EUA Termination or Revocation

In general, an EUA will remain in effect for the duration of the HHS EUA declaration under which it was issued. There are two mechanisms, termination or revocation, that result in an EUA test no longer being authorized:

  1. If a supporting HHS EUA declaration is terminated, then the termination of all EUAs issued pursuant to the declaration occurs on the effective date of the termination of HHS’s declaration. On that date, such EUAs will no longer be in effect.
  2. Individual EUAs may be revoked by FDA if the circumstances justifying its issuance no longer exist, the criteria for its issuance are no longer met, or other circumstances make revocation appropriate to protect the public health or safety.

A number of circumstances are described in more detail in the FDA Guidance Document: Emergency Use Authorization of Medical Products and Related Authorities. Some circumstances that may result in the revocation of individual EUAs include: reports of adverse events (number or severity) linked to, or suspected of being caused by, the EUA product; product failure; change in approval status of the EUA product (e.g., the same product receives full marketing authorization such as with a Premarket Approval (PMA) or granting of a De Novo classification request); request from the EUA holder to revoke the EUA (e.g., the product is no longer manufactured).

Since a criterion for the issuance of an EUA is that there is no adequate, approved, and available alternative, when an EUA product subsequently receives full marketing authorization, such product may be an adequate, approved and available alternative to EUA products.  In such cases, FDA anticipates providing notice of intent to revoke to the remaining relevant EUA holders and an invitation to the holder of the full marketing authorization to comment on the extent to which their product is or is not an adequate, approved, and available alternative to existing EUA products. While FDA is undertaking this revocation process, the current active EUA products remain authorized.

When an EUA is revoked or terminated, there will be a date beyond which the test(s) can no longer be used. The EUA holder of the revoked or terminated EUA is advised to instruct laboratories to discontinue use of and discard any remaining EUA product inventory in accordance with the terms of the revocation or termination.

Laboratories are also encouraged to routinely check FDA’s list of active EUA products for the latest list of active EUAs and any updates to the EUA product granted through amendment. EUA products that have been terminated as a result of the termination of the supporting HHS EUA declaration or revoked by FDA even though the HHS EUA declaration is still in effect, are immediately removed from FDA’s active EUA products webpage. Information about EUAs that are no longer in effect is available on our EUA archive page. Notice of EUA revocations and terminations are also published in the Federal Register.

Using a Test:  General Q&A

1. How do I report performance concerns?

The letter of authorization will prescribe to whom and how to report performance concerns. Typically, laboratory personnel using diagnostic assays under EUA are encouraged to report performance concerns directly to FDA at [email protected], in addition to reporting concerns to the manufacturer.

2. Does an EUA test need to be used in a manner consistent with the authorized labeling?

Yes. Clinical diagnostic use of an IVD assay under EUA must follow the procedures outlined in the manufacturer’s Instructions for Use and the terms and conditions of authorization outlined in the authorization letter.  Deviations from the procedures outlined are not permitted under the EUA. For example, if a laboratory is requested to test specimens that are not authorized with the specific test, then testing the requested specimen would be an illegal use of the test. In this example, the laboratory is encouraged to contact FDA at [email protected].

3. Is it necessary to provide Fact Sheets with every test result?  Where can I find Fact Sheets?

When providing test results to healthcare providers and patients, laboratories must include a copy of the authorized fact sheets along with reports of the test results. Under exigent circumstances, other appropriate methods for disseminating fact sheets may generally be used, as described in the EUA Authorization Letter for a specific test, which may include mass media. Printable fact sheets specific for each EUA IVD are available on our EUA webpage.

4. Can I make changes to the test to improve it without contacting FDA?  Can laboratories develop the data necessary to add claims, instruments or specimen types, etc., to an existing EUA for an IVD?

An EUA IVD must be used as outlined in the Authorization Letter and Instructions for Use. If you have suggested improvements, then FDA recommends that you contact the EUA holder/ test manufacturer (contact information is provided in the authorized manufacturer’s Instructions for Use). The EUA holder can update their Instructions for Use in an amendment to the EUA, given FDA review of appropriate data.  Similarly, if a laboratory wishes to see a claim, instrument or specimen, etc., added to an existing EUA IVD then they should work with the EUA holder to amend the EUA.

5. What happens when an EUA is revoked or terminated?

If an EUA is revoked or terminated, then there will be a date beyond which the test can no longer be used for clinical diagnostic purposes. (See: Guidance: Emergency Use Authorization of Medical Products and Related Authorities section III.G.)

6. Where can I find information related to CLIA as applied to assays used under an EUA? 

The Centers for Medicare and Medicaid Services recently published a memo to their surveyors explaining policy related to the Clinical Laboratory Improvement Amendments (CLIA) regulations as they apply to assays used under an EUA. This memo discusses laboratory compliance with CLIA regulations and the verification of performance specifications for EUA IVD assays.

Contact FDA

If you have additional questions, contact [email protected].

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