Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
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.
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. The FDA has authorized molecular and antigen diagnostic tests for SARS-CoV-2, including multi-analyte tests that detect SARS-CoV-2 as well as other respiratory pathogens, and serology/antibody tests for SARS-CoV-2. The FDA has also authorized tests for use in the management of patients with COVID-19.
Tables of IVD EUAs can be found for each type of COVID-19 test:
FDA does not plan to take any action that would leave the American public without the tests they need. We recognize that manufacturers of devices 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declaration under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that allows FDA to issue EUAs is no longer in effect.
It is important to note the distinction between the public health emergency determination under section 319 of the Public Health Service 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). The COVID-19 PHE declaration was issued on January 31, 2020 and has been extended every three months since then. The PHE declaration may expire if not extended. In contrast, the EUA declaration under section 564 continues until the HHS Secretary terminates it, and it is not dependent upon extension of the PHE declaration. Many previous EUA declarations, such as for MERS, Zika, and Ebola, remain in effect; this is especially true for in vitro diagnostic tests. Additional information on the different declarations, and what happens when an EUA declaration is terminated, can be found on our website here: FAQs: What happens to EUAs when a public health emergency ends? | FDA
On December 23, 2021, FDA issued a draft guidance, "Transition Plan for Medical Devices Issued EUAs During the COVID-19 Public Health Emergency," describing the steps FDA recommends manufacturers take to transition medical devices issued EUAs to full marketing authorization. The draft guidance proposes that there will be at least a 180-day transition period. FDA will finalize the guidance after considering public comments on the draft.
The draft transition guidance describes a proposed policy that, when a COVID-19 EUA declaration is terminated, FDA does not intend to object to the continued distribution of devices authorized pursuant to that declaration after the EUA termination date where a manufacturer's full marketing submission (submitted and accepted before the EUA termination date) is under review. In general, any final full marketing authorization (i.e., granted de novo or cleared 510(k)) would include the conditions and settings in which the test could be used, including beyond the emergency and transition period. Any test that receives full marketing authorization would also be subject to a CLIA categorization.
If test developers have questions about how to manage their current plans for moving forward now with their emergency use authorized test or with a 510(k) or other full marketing submission, we encourage them to send an email to the EUA templates mailbox with sufficient details so that we can provide appropriate feedback.
Notably, we have already granted a de novo and cleared a 510(k) for COVID-19 molecular tests. We welcome additional 510(k) submissions for molecular tests. While we have not yet granted full marketing authorization for antigen or serology tests, we are interested in doing so. A de novo submission would be the appropriate pathway for each of those.
A: As discussed in the FDA's Policy for Coronavirus Disease-2019 Tests, reissued on November 15, 2021, 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.
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 addition, FDA understands that some laboratory developed tests (LDTs) for SARS-CoV-2 are being offered without FDA authorization or submission of an EUA request following an August 2020 HHS Announcement. In the updated guidance, the FDA describes policies for the review of EUA requests for COVID-19 tests offered prior to November 15 as described in the notification policies or following the August 2020 HHS announcement, 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.
Previous versions of this guidance also 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 FDA and the laboratory does not submit an EUA request to FDA. As stated in the updated guidance, 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 date of issuance of this updated guidance that are continuing to authorize laboratories within that State or territory to develop and perform a test for COVID-19, 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 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.
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 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.
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 FDA. Until the test is authorized by FDA, any statements in the test reports and other labeling that expressly state or imply that the test has been authorized by 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.
- 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.
- Instructions for use and patient test reports for serology tests 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 (i.e., 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.
For tests being distributed or offered during FDA review, as described in the policies in Section IV.C of the guidance, FDA generally expects developers to cease 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 FDA identifies a significant problem or concern with a test, based either on the provided information or external reports, 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.
A: As discussed in the FDA's Policy for Coronavirus Disease-2019 Tests, reissued on November 15, 2021, the FDA no longer intends to add tests to the notification lists. Further, for tests already on the notification lists, 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.
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 the previous version of the guidance. Going forward, these notification lists will reflect only those tests for which FDA review is pending. Once a test is authorized or 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 and/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, FDA generally expects developers to cease 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 FDA identifies a significant problem or concern with a test, based either on the provided information or external reports, 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.
A: No. 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, or CLIA, which is administered by 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, reissued on November 15, 2021.
A: No. 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, or CLIA, which is administered by 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 [email protected].
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).
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 updated guidance, issued November 15, 2021, 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 date of issuance of this updated guidance that are continuing to authorize laboratories within that State or territory to develop and perform a test for COVID-19, 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 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 guidance, 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
A: As discussed in the FDA's Policy for Coronavirus Disease-2019 Tests, reissued on November 15, 2021, 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.
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 updated guidance, the FDA describes 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 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 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 November 15, 2021, the FDA no longer intends to add tests to the notification lists. Further, for tests already on the notification lists, 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, FDA generally expects developers to cease distributing, marketing, and offering their tests within 15 calendar days. Moreover, if FDA identifies a significant problem or concern with a test, based either on the provided information or external reports, 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.
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 |
|---|---|---|
| Alphadera Labs, LLC | Not FDA Authorized | H |
| Bako Pathology Associates/DBA Bako Diagnostics | Not FDA Authorized | H |
| Baylor University Medical Center Department of Pathology | Not FDA Authorized | H |
| BioBridge Global (BBG) | Not FDA Authorized | H |
| Capital Digestive Care, LLC., Laboratory Services | Not FDA Authorized | H |
| Essentia Health East- SMDC Laboratory | Not FDA Authorized | H |
| Genomic Expression | Not FDA Authorized | H |
| HFI Laboratory at Boston University dba Boston University Clinical Testing Laboratory | Not FDA Authorized | H |
| LynxDx | Not FDA Authorized | H |
| MD Tox Laboratory DBA Innovative Health Diagnostics | Not FDA Authorized | H |
| MedArbor Diagnostics | Not FDA Authorized | H |
| Medical College of Wisconsin | Not FDA Authorized | H |
| New York Presbyterian Hospital - Weill Cornell Medicine (NYPH-WCM) | Not FDA Authorized | H |
| NOAH Associates | Not FDA Authorized | H |
| Olin Health Center, Michigan State University | Not FDA Authorized | H |
| Opteo Laboratory, LLC | Not FDA Authorized | H |
| RAS Medical Solutions | Not FDA Authorized | H |
| Santa Clara Valley Medical Center Clinical Laboratory | Not FDA Authorized | H |
| TAAG Genetics Corp | Not FDA Authorized | H |
| Tallahassee Memorial HealthCare | Not FDA Authorized | H |
| TGen North, Clinical Laboratory | Not FDA Authorized | H |
| University of Washington | Not FDA Authorized | H |
| Valley Medical and Wellness Laboratory | Not FDA Authorized | H |
| Virginia Tech Schiffert Health Center | Not FDA Authorized | H |
| SummerBio Labs | 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.
A: As discussed in the FDA's Policy for Coronavirus Disease-2019 Tests, reissued on November 15, 2021, 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.
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 updated guidance, the FDA describes 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 November 15, 2021, the FDA no longer intends to add tests to the notification lists. Further, for tests already on the notification lists, 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, FDA generally expects developers to cease distributing, marketing, and offering their tests within 15 calendar days. Moreover, if FDA identifies a significant problem or concern with a test, based either on the provided information or external reports, 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 |
|---|---|---|
| ELITechGroup MDx LLC SARS-CoV-2 ELITe MGB Assay | Not FDA Authorized | H |
| Genetic Signatures Limited, EasyScreen™ SARS-CoV-2 Detection Kit RP012 | Not FDA Authorized | H |
| Biocartis NV, Idylla™ SARS-CoV-2 Test | Not FDA Authorized | H |
| Chai Inc., COVID-19 Saliva Dx Test Kit | Not FDA Authorized | H |
| 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 |
| Biotrack BV, Escher BT-MED® COV19 Test | Not FDA Authorized | H |
| Baebies Inc., FINDER SARS-CoV-2 Test (used with FINDER 1.5 instrument) | Not FDA Authorized | H |
| Delphine Diagnostics Inc., Delphine PrecisQT™ COVID-19 Test Kit | Not FDA Authorized | H |
| QIAGEN GmbH, artus® SARS-CoV-2 Prep&Amp UM Kit | Not FDA Authorized | H |
| LG CHEM Ltd., AdvanSure™ One-Stop COVID-19 Kit | Not FDA Authorized | H |
| Bioneer Corporation AccuPower®SARS-CoV-2 Multiplex Real-Time | 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.
A: As discussed in the FDA's Policy for Coronavirus Disease-2019 Tests, reissued on November 15, 2021, 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.
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 updated guidance, the FDA describes 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 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 FDA prior to November 15, 2021, that they had validated and intended to offer serology tests as described in Section IV.D 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 November 15, 2021, the FDA no longer intends to add tests to the notification lists. Further, for tests already on the notification lists, 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, FDA generally expects developers to cease distributing, marketing, and offering their tests within 15 calendar days. Moreover, if FDA identifies a significant problem or concern with a test, based either on the provided information or external reports, 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.
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.
Tests that have been issued an EUA can be found on the EUA page.
Laboratory Serology Test Notification List:
| Laboratory | Authorization Status | Settings for Use1 |
|---|---|---|
| Houston Methodist-Pathology | 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.
A: As discussed in the FDA's Policy for Coronavirus Disease-2019 Tests, reissued on November 15, 2021, 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.
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 updated guidance, the FDA describes 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 serology tests as set forth in Section IV.D 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 November 15, 2021, the FDA no longer intends to add tests to the notification lists. Further, for tests already on the notification lists, 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, FDA generally expects developers to cease distributing, marketing, and offering their tests within 15 calendar days. Moreover, if FDA identifies a significant problem or concern with a test, based either on the provided information or external reports, 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 Serology Test Notification List:
| Manufacturer and Test | Authorization Status | Settings for Use1 |
|---|---|---|
| Boditech Med Inc AFIAS COVID-19 Ab serological tests | 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.