Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2

November 8, 2023 - The COVID-19 public health emergency (PHE) declared under section 319 of the Public Health Service (PHS) Act expired on May 11, 2023. The COVID-19 enforcement policy guidances within scope of the Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (see List 1) are no longer in effect.

The end of the COVID-19 PHE and certain COVID-19 enforcement policy guidances no longer being in effect do not impact the FDA's ability to authorize devices, including tests, for emergency use. Existing emergency use authorizations (EUAs) for devices relating to COVID-19 remain in effect under section 564 of the Federal Food, Drug, and Cosmetic Act. The FDA encourages manufacturers of devices issued EUAs related to COVID-19 to review the guidance: Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19), which outlines the FDA's recommendations and expectations to such manufacturers to transition to normal operations when the declarations that allowed for FDA to issue EUAs under section 564 of the Federal Food, Drug, and Cosmetic Act end. Additional information is provided on the page FAQs: What happens to EUAs when a public health emergency ends?

This page is part of the FAQs on Testing for SARS-CoV-2 and provides answers to frequently asked questions related to Emergency Use Authorizations and Notifications as described in the policies in the Policy for Coronavirus Disease-2019 Tests.

Questions and answers regarding other policies described in the Policy for Coronavirus Disease-2019 Tests are found in other pages in this section.

Q: What in vitro diagnostic tests for COVID-19 have been issued an Emergency Use Authorization or marketing authorization? (9/27/22)

A: All in vitro diagnostic tests that have been issued an Emergency Use Authorization (EUA) are listed on the COVID-19 In Vitro Diagnostics EUAs page.

Tables of in vitro diagnostic test EUAs can be found for each type of COVID-19 test:

On March 17, 2021, the FDA granted the first marketing authorization using the De Novo review pathway for the BioFire Respiratory Panel 2.1 (RP2.1). On November 1, 2021, the FDA cleared the first 510(k) for the BioFire COVID-19 Test 2.

Q: What will happen with tests offered under EUA when the public health emergency under the Public Health Service Act expires? (5/12/23)

The FDA does not plan to take any action that would leave Americans without the tests they need. We recognize that manufacturers of tests that were issued EUAs will need an appropriate period to transition to normal operations when the emergency use declaration under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that allows the FDA to issue EUAs is no longer in effect.

The Public Health Emergency and Emergency Use Authority

It is important to note the distinction between the public health emergency (PHE) determination under section 319 of the Public Health Service Act (PHS Act) (the PHE declaration) and the separate declaration under section 564 of the FD&C Act that enables the issuance of EUAs (the EUA declaration) related to COVID-19. The COVID-19 PHE declaration was issued on January 31, 2020, and has been extended every three months since. The PHE declaration lasts for 90 days unless the Secretary of Health and Human Services (HHS) either extends it or declares the emergency no longer exists. On February 11, 2023, the HHS Secretary announced that the COVID-19 PHE declaration would expire on May 11, 2023.

In contrast, the EUA declarations related to COVID-19 under section 564 of the FD&C Act continue until the HHS Secretary terminates them. An EUA declaration is distinct from, and not dependent on, the PHE declaration under section 319 of the PHS Act, and, therefore, an EUA may remain in effect beyond the duration of a PHE declaration if other statutory conditions are met. EUAs may remain authorized and new EUAs may continue being issued so long as the applicable EUA declaration remains in effect. Many previous EUA declarations, such as for MERS, Zika, and Ebola, remain in effect. Additional information on the different declarations, and what happens when an EUA declaration is ended, can be found on our website here: FAQs: What happens to EUAs when a public health emergency ends?

Transition Plan

On March 24, 2023, the FDA issued a guidance, Transition Plan for Medical Devices Issued EUAs Related to COVID-19, describing the recommendations to transition from policies adopted and operations implemented during the COVID-19 pandemic to normal operations. This includes recommendations to transition medical devices issued EUAs related to COVID-19 to traditional marketing authorization. This guidance is referred to as the "Transition Plan guidance" on this page. The Transition Plan guidance states that there will be an advance notice of termination 180 days prior to an EUA declaration termination.

The Transition Plan guidance describes a policy that, when the EUA declaration under section 564 of the FD&C Act relating to in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated, the FDA does not intend to object to the continued distribution of tests after that date where the test was previously issued an EUA and the manufacturer 's traditional marketing submission (submitted and accepted before the EUA declaration termination date) is under review. Any test that receives traditional marketing authorization would also be subject to a Clinical Laboratory Improvement Amendments (CLIA) categorization.

Traditional Marketing Authorization and Submissions

If test developers have questions about their current plans for their EUA- authorized test or questions about a future 510(k) or other traditional marketing submission, the FDA encourages them to contact us one of these ways:

Send an email to the EUA templates mailbox with sufficient details so the FDA can provide appropriate feedback, or
Submit a Pre-Submission (also known as a Q-Submission) for your COVID-19 test. Please review the guidance: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program for additional information about this program.

Notably, the FDA has already begun authorizing COVID-19 tests through traditional premarket review pathways. COVID-19 tests that have been cleared or granted de novo classification can be found in FDA's medical devices databases for 510(k) and De Novo.

The FDA welcomes additional marketing submissions for COVID-19 tests.

Q: What is the FDA's policy regarding distribution and offering of COVID-19 tests during FDA review? (9/27/22)

A: As discussed in the FDA's Policy for Coronavirus Disease-2019 Tests, reissued on September 27, 2022, the FDA generally expects COVID-19 tests to have been issued an Emergency Use Authorization (EUA) or marketing authorization [PMA, De Novo, 510(k)] prior to the tests being distributed or offered. As explained throughout this updated guidance, the FDA intends to review the EUA requests for a smaller subset of tests based on the review priorities described in section IV.A. Traditional marketing pathways remain available to all developers and the FDA encourages developers of tests that fall outside the scope of the priorities outlined in this updated guidance to pursue those routes.

Previous versions of this guidance described policies regarding the distribution and offering of certain tests for clinical use prior to or without an EUA, often referred to as the notification policies. Those policies were updated in the November 15, 2021, version of the guidance, and the FDA is generally continuing those updated policies and clarifying them, as discussed in the current version of the Policy for Coronavirus Disease-2019 Tests.

For tests being distributed or offered during FDA review, as described in the policies in Section IV.C of the guidance, the FDA generally expects test developers to stop distributing, marketing, and offering their tests within 15 calendar days of email notification by the FDA that the FDA declines to review, declines to issue, or otherwise decides not to authorize the test for any reason, including lack of response or a determination that there is a lack of adequate data to support authorization. Moreover, if the FDA identifies a significant problem or concern with a test, based either on the provided information or external reports, the FDA generally would expect the developer to take appropriate steps to address such problems, which could include conducting a recall of the test and/or notification concerning corrected test reports indicating prior test results may not be accurate.

Clinical Laboratory Improvement Amendments (CLIA)

Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under the Clinical Laboratory Improvement Amendments (CLIA), section 353 of the Public Health Service Act (42 USC 263a), use of that test is limited to laboratories that are certified under CLIA, and meet the requirements to perform tests of high-complexity, and at the point-of-care (POC) when covered by such a laboratory's CLIA certificate.

The policies regarding offering a COVID-19 test prior to or without an EUA have never applied to at-home tests or tests with home specimen collection, or any testing outside of a high-complexity CLIA-certified laboratory. Further, the notification policies in the Policy for Coronavirus Disease-2019 Tests have never applied to multi-analyte respiratory panels.

FDA Recommendations for Test Reports and Publicly Available Information

As discussed in the guidance, the FDA provides recommendations regarding test reports and other information for tests offered during FDA review of EUA requests. Specifically, the FDA recommends that:

Test reports should prominently disclose that the test has not been reviewed by the FDA. Until the test is authorized by the FDA, any statements in the test reports and other labeling that expressly state or imply that the test has been authorized by the FDA would be false. Similarly, any statements in the test reports and other labeling that state or imply that EUA issuance or FDA authorization are imminent or pending could be misleading.
Test developers should make publicly available on their website the instructions for use for the test and data about the test's performance characteristics, including a summary of assay performance.
Serology test instructions for use and patient test reports should include information that helps users and patients understand the test results, including the following:
- Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct diagnostic testing for SARS-CoV-2 is necessary.
- Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

States and Territories

Previous versions of this guidance described a policy regarding States and territories that authorize laboratories within their State or territory to develop their own COVID-19 tests and perform specimen testing, where the notification of SARS-CoV-2 test validation is not submitted to the FDA and the laboratory does not submit an EUA request to the FDA. In the November 15, 2021 version of this guidance, the FDA revised this policy such that the FDA no longer intends to apply the policy to any additional States or territories going forward. For the States and territories listed on the notification list on the FDA's website prior to November 15, 2021, that are continuing to authorize laboratories within that State or territory to develop and perform a test for COVID-19, the FDA does not intend to object to the use of such tests for specimen testing where the notification of SARS-CoV-2 test validation is not submitted to the FDA and the laboratory does not submit an EUA request to the FDA, and where instead the State or territory takes responsibility. This policy applies only to tests designed, developed, and used within a single, high-complexity CLIA-certified laboratory. This policy does not apply to at-home tests or tests with home specimen collection, or any testing outside of a high-complexity CLIA-certified laboratory.

Q: Is the FDA maintaining the notification lists that reflected tests offered as described in the notification policies in previous versions of the Policy for Coronavirus Disease-2019 Tests or the removal lists that reflected tests that should no longer be used or distributed for COVID-19? (9/27/22)

A: As discussed in the November 2021 version of the FDA's Policy for Coronavirus Disease-2019 Tests and maintained in the current version of the guidance, the FDA no longer intends to add tests to the notification lists. Further, for tests already on the notification lists, the FDA intends to remove tests for which the FDA has either issued an EUA or has notified the test developer by email that the FDA declines to review, declines to issue, or otherwise decides not to authorize the test for any reason.

The FDA intends to maintain the notification lists for laboratories and commercial manufacturers distributing and offering diagnostic tests and serology tests as described in the policies in Sections IV.A, IV.C, and IV.D of previous versions of the guidance. Going forward, these notification lists will reflect only those tests for which the FDA review is pending. Once a test is authorized or the FDA has notified the test developer that the FDA declines to review, declines to issue, or otherwise decides not to authorize the test for any reason, the test will be removed from the notification list.

The FDA does not intend to maintain the removal lists of tests that should no longer be used or distributed for COVID-19. For tests being distributed or offered during FDA review, as described in the policies in Section IV.C of the guidance, the FDA generally expects developers to stop distributing, marketing, and offering their tests within 15 calendar days of email notification by the FDA that the FDA declines to review, declines to issue, or otherwise decides not to authorize the test for any reason, including lack of response or a determination that there is a lack of adequate data to support authorization. Moreover, if the FDA identifies a significant problem or concern with a test, based either on the provided information or external reports, the FDA generally would expect the developer to take appropriate steps to address such problems, which could include conducting a recall of the test and/or notification concerning corrected test reports indicating prior test results may not be accurate.

The FDA intends to maintain the notification list for States and territories that have chosen to authorize laboratories within that State or territory to develop and perform a test for COVID-19 as described in the policy in Section IV.B of the guidance.

Q: I am a laboratory offering COVID-19 testing with an EUA-authorized test. Should I notify the FDA? (11/15/21)

A: No. The FDA does not expect any notification from laboratories that are performing testing using EUA-authorized tests. Facilities performing COVID-19 testing must be certified under the Clinical Laboratory Improvement Amendments (CLIA), which is administered by the Centers for Medicare and Medicaid Services (CMS).

Laboratories authorized to use EUA-authorized tests are subject to various conditions that can be found in the EUA.

Each EUA also includes the settings in which the test is authorized. For ease of reference, the settings authorized in the EUAs are also noted in the EUA table on the In Vitro Diagnostics EUA page.

Tests that are noted with an "H" in the Authorized Settings are limited to use in laboratories certified under CLIA that meet requirements to perform high-complexity tests.
Tests that are noted with an "H" and "M" in the Authorized Settings may be performed in laboratories certified under CLIA that meet requirements to perform high complexity and/or moderate complexity tests.
Tests that are noted with a "W" in the Authorized Settings are deemed to be CLIA-waived for use in patient care settings operating under a CLIA Certificate of Waiver.
Tests noted with an "H," "M," and "W" may be used in laboratories certified under CLIA that meet requirements to perform high complexity and/or moderate complexity tests and in patient care settings operating under a CLIA Certificate of Waiver.

Laboratories should also be aware of the FDA's policies regarding modifications to EUA-authorized diagnostic COVID-19 tests, which are discussed in Section IV.D of the Policy for Coronavirus Disease-2019 Tests.

Q: I am a laboratory offering COVID-19 testing with a test listed on a notification list. Should I notify FDA? (11/15/21)

A: No. The FDA does not expect any notification from laboratories that are performing testing using tests that are listed on a notification list.

Facilities performing COVID-19 testing must be certified under the Clinical Laboratory Improvement Amendments (CLIA), which is administered by the Centers for Medicare and Medicaid Services (CMS).

Tests on a notification list are identified as "Not FDA Authorized," indicating that they have not yet been reviewed by the FDA, are not FDA authorized, and have not received a CLIA categorization.

Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory's CLIA certificate for high-complexity testing.

Laboratories offering such tests may be subject to additional requirements regarding establishment of performance specifications under the CLIA Regulations. Laboratories with questions about these requirements should contact CMS at LabExcellence@cms.hhs.gov.

As outlined in FDA's Guidance for Industry and Food and Drug Administration Staff: Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only, tests that are intended for clinical use should not be labeled as "for research use only" (RUO).

Q: What States or territories have chosen to authorize laboratories within that State or territory to develop and perform a test for COVID-19 as described in the policy in Section IV.B of the Policy for Coronavirus Disease-2019 Tests? (9/27/22)

A: As stated in Section IV.B of the FDA's Policy for Coronavirus Disease-2019 Tests, previous versions of the guidance described a policy regarding States and territories choosing to authorize laboratories within that State or territory to develop and perform a test for COVID-19 under authority of its own State law, and under a process that it establishes. As discussed in the November 2021 version of the guidance, and maintained in the September 2022 version, the FDA no longer intends to apply the policy to any additional States or territories going forward.

For the States and territories listed on the notification list on FDA's website prior to the issuance of the November 15, 2021, version of the guidance that are continuing to authorize laboratories within that State or territory to develop and perform a test for COVID-19, the FDA does not intend to object to the use of such tests for specimen testing where:
- The notification of SARS-CoV-2 test validation is not submitted to FDA, and
- The laboratory does not submit an EUA request to the FDA, and
- Where instead the State or territory takes responsibility.
This policy applies only to tests designed, developed, and used within a single, high-complexity CLIA-certified laboratory.
This policy does not apply to at-home tests or tests with home specimen collection, or any testing outside of a high-complexity CLIA-certified laboratory.

The States and territories listed below have notified FDA prior to November 15, 2021, that they choose to authorize laboratories as described in this policy. As stated in the policy, the FDA has not reviewed the process adopted by the State or territory and is including this list here to provide transparency regarding the notifications submitted to FDA.

Puerto Rico Department of Health
State of Colorado
State of Connecticut
State of Maryland
State of Mississippi
State of Nevada
State of New Jersey
State of New York Department of Health Wadsworth Center
Washington State Department of Health

Q: Laboratory Diagnostic Test Notification List - What laboratories are offering SARS-CoV-2 diagnostic tests during FDA review as described in a policy in the Policy for Coronavirus Disease-2019 Tests? (10/23/23)

A: As discussed in the November 2021 version of the FDA's Policy for Coronavirus Disease-2019 Tests, and maintained in the September 2022 version, the FDA generally expects COVID-19 tests to have been issued an Emergency Use Authorization (EUA) or marketing authorization [PMA, De Novo, 510(k)] prior to the tests being distributed or offered.

The policies regarding offering a COVID-19 test prior to an EUA have never applied to at-home tests or tests with home specimen collection, or any testing outside of a high-complexity CLIA-certified laboratory.

The laboratories listed below notified the FDA prior to November 15, 2021, that they had validated and intended to offer diagnostic tests as described in Section IV.A of the previous versions of the guidance.

All tests included on the notification list are "Not FDA Authorized," indicating that the FDA has not yet reviewed the developer's validation and issued an EUA for the test, and the test is included in this list to provide transparency regarding the notification submitted to FDA.
The "Setting for Use" designation of "H" refers to a laboratory certified under CLIA to perform high-complexity testing.

As discussed in the FDA's Policy for Coronavirus Disease-2019 Tests, reissued on September 27, 2022,

The FDA is maintaining the policy announced in the November 15, 2021 version of the guidance and no longer intends to add tests to the notification lists.
For tests already on the notification lists, the FDA intends to remove tests for which the FDA has either issued an EUA or has notified the test developer by email that the FDA declines to review, declines to issue, or otherwise decides not to authorize the test for any reason.
- If so notified, the FDA generally expects developers to stop distributing, marketing, and offering their tests within 15 calendar days.
- If the FDA identifies a significant problem or concern with a test, based either on the provided information or external reports, the FDA generally would expect the developer to take appropriate steps to address such problems, which could include conducting a recall of the test and/or notification concerning corrected test reports indicating prior test results may not be accurate.

The FDA updates the list regularly. It is important to note that, due to changes in policies and practices over the course of the public health emergency, among other things, this list may not be a complete or accurate list of laboratories offering tests during FDA review as described in Section IV.C of the current version of the Policy for Coronavirus Disease-2019 Tests. Additionally, the laboratories listed here, and other laboratories, may be offering other tests that have been issued an EUA or certain modified tests as described in Section IV.D of the current version of the FDA's Policy for Coronavirus Disease-2019 Tests.

Tests that have been issued an EUA can be found on the EUA page.

Laboratory Diagnostic Test Notification List:

Laboratory	Authorization Status	Settings for
TAAG Genetics Corp	Not FDA Authorized	H

¹Settings for use include the following:

H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
W - Patient care settings operating under a CLIA Certificate of Waiver.

Q: Commercial Manufacturer Diagnostic Test Notification List - What commercial manufacturers are distributing SARS-CoV-2 diagnostic tests during FDA review as described in a policy in the Policy for Coronavirus Disease-2019 Tests? (8/31/2023)

Previous versions of this guidance described policies regarding the distribution and offering of certain tests for clinical use prior to or without an EUA, often referred to as the notification policies. In the November 2021 version of the guidance and maintained in the September 2022 version, the FDA described policies for the review of EUA requests for COVID-19 tests offered prior to November 15, 2021, as described in the notification policies, and the policies regarding distribution and offering of such tests during FDA review. The details of these policies can be found in Section IV.C of the Policy for Coronavirus Disease-2019 Tests. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under the Clinical Laboratory Improvement Amendments (CLIA), section 353 of the Public Health Service Act (42 USC 263a), use of that test is limited to laboratories that are certified under CLIA, and meet the requirements to perform tests of high-complexity, and at the point-of-care (POC) when covered by such a laboratory's CLIA certificate.

The policies regarding offering a COVID-19 tests prior to an EUA have never applied to at-home tests or tests with home specimen collection, or any testing outside of a high-complexity CLIA-certified laboratory. The commercial manufacturers listed below notified FDA prior to November 15, 2021, that they had validated and intended to distribute diagnostic tests as described in Section IV.C of the previous versions of FDA's Policy for Coronavirus Disease-2019 Tests.

All tests included on the notification list are "Not FDA Authorized," indicating that the FDA has not yet reviewed the manufacturer's validation and issued an EUA for the test, and the test is included in this list to provide transparency regarding the notification submitted to FDA.
The "Setting for Use" designation of "H" refers to a laboratory certified under CLIA to perform high-complexity testing.

As discussed in the FDA's Policy for Coronavirus Disease-2019 Tests, reissued on September 27, 2022,

The FDA is maintaining the policy announced in the November 15, 2021 version of the guidance and the FDA no longer intends to add tests to the notification lists.
For tests already on the notification lists, the FDA intends to remove tests for which FDA has either issued an EUA or has notified the test developer by email that FDA declines to review, declines to issue, or otherwise decides not to authorize the test for any reason.
- If so notified, the FDA generally expects developers to cease distributing, marketing, and offering their tests within 15 calendar days.
- If FDA identifies a significant problem or concern with a test, based either on the provided information or external reports, the FDA generally would expect the developer to take appropriate steps to address such problems, which could include conducting a recall of the test and/or notification concerning corrected test reports indicating prior test results may not be accurate.

Tests that have been issued an EUA can be found on the EUA page.

Commercial Manufacturer Diagnostic Test Notification List:

Manufacturer and Test	Authorization Status	Settings for Use¹
Tetracore, Inc., EZ-SARS-CoV-2 Real-Time RT-PCR	Not FDA Authorized	H
LMSI, LLC d/b/a Lighthouse Lab Services, SalivaNow SARS-CoV-2 Assay Kit	Not FDA Authorized	H

¹ Settings for use include the following:

H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
W - Patient care settings operating under a CLIA Certificate of Waiver.

Q: Laboratory Serology Test Notification List - What laboratories are offering SARS-CoV-2 serology tests during FDA review as described in a policy in the Policy for Coronavirus Disease-2019 Tests? (11/10/22)

A: All tests that were previously on this list have now been removed from the notification list because the FDA either issued an Emergency Use Authorization (EUA) for the test or the FDA sent a notification to the test developer by email that the FDA declined to review, declined to issue, or otherwise decided not to authorize the test.

The FDA expects that developers whose tests were previously on the Laboratory Serology Test Notification List will have stopped distributing, marketing, and offering their tests unless those tests have an EUA or marketing authorization [PMA, De Novo, 510(k)]. Currently, there are no COVID-19 serology tests that have been FDA cleared or approved. However, serology tests with an EUA can be found on the EUA page.

Further, as discussed in the FDA's Policy for Coronavirus Disease-2019 Tests, reissued on September 2022, the FDA is maintaining the policy announced in the November 15, 2021 version of the guidance and the FDA no longer intends to add tests to the notification lists on FDA.gov. See the FDA's Policy for Coronavirus Disease-2019 Tests, for more information on the FDA's current policies.

Q: Commercial Manufacturer Serology Test Notification List - What commercial manufacturers are distributing serology tests during FDA review as described in a policy in the Policy for Coronavirus Disease-2019 Tests? (9/27/22)

The FDA expects that developers whose tests were previously on the Commercial Manufacturer Serology Test Notification List will have stopped distributing, marketing, and offering their tests unless those tests have an EUA or marketing authorization [PMA, De Novo, 510(k)]. Currently, there are no COVID-19 serology tests that have been FDA cleared or approved. However, serology tests with an EUA can be found on the EUA page.