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:
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 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).
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 |
---|---|---|
Access Medical Laboratories | Not FDA Authorized | H |
Accu Reference Medical Lab LLC | Not FDA Authorized | H |
Advanced Diagnostics Laboratory, National Jewish Health | Not FDA Authorized | H |
AdventHealth | Not FDA Authorized | H |
Aegis Sciences Corporation | Not FDA Authorized | H |
Alphadera Labs, LLC | Not FDA Authorized | H |
ARUP Laboratories | Not FDA Authorized | H |
Bako Pathology Associates/DBA Bako Diagnostics | Not FDA Authorized | H |
Baylor College of Medicine (CMMR/HGSC) Clinical Laboratories | Not FDA Authorized | H |
Baylor Scott and White Medical Center - Temple | Not FDA Authorized | H |
Baystate Medical Center Whitney Ave Laboratories | Not FDA Authorized | H |
Bedford Research Foundation | Not FDA Authorized | H |
Beth Israel Deaconess Medical Center | Not FDA Authorized | H |
Brigham and Women's Hospital | Not FDA Authorized | H |
Bryan Medical Center West | Not FDA Authorized | H |
Children's National Hospital | Not FDA Authorized | H |
Clarity Lab Solutions | Not FDA Authorized | H |
Clinical Laboratory University Hospital at University of Arkansas for Medical Sciences | Not FDA Authorized | H |
Clinical Pathology Laboratories | Not FDA Authorized | H |
Consolidated Medical Bio-Analysis, Inc. | Not FDA Authorized | H |
Coppe Laboratories | Not FDA Authorized | H |
Davis Medical Center | Not FDA Authorized | H |
Devansh Lab Werks Inc. | Not FDA Authorized | H |
Dynamic DNA Laboratories, LLC | Not FDA Authorized | H |
Emory Medical Laboratory, Emory Healthcare | Not FDA Authorized | H |
Genesys Diagnostics Inc. | Not FDA Authorized | H |
Henry Ford Health System | Not FDA Authorized | H |
Hospital of the University of Pennsylvania | Not FDA Authorized | H |
iGenomeDx | Not FDA Authorized | H |
J Randolph Schnitman MD Inc. | Not FDA Authorized | H |
Johns Hopkins Medical Microbiology Laboratory at Johns Hopkins Hospital | Not FDA Authorized | H |
Kansas State Veterinary Diagnostic Laboratory | Not FDA Authorized | H |
Lehigh Valley Genomics | Not FDA Authorized | H |
Lexar Laboratories & Analysis, LLC | Not FDA Authorized | H |
MAWD Pathology Group | Not FDA Authorized | H |
Mayo Clinic - Rochester, MN | Not FDA Authorized | H |
MD Tox Laboratory DNA Innovative Health Diagnostics | Not FDA Authorized | H |
Medical College of Wisconsin | Not FDA Authorized | H |
Medical Diagnostic Laboratories LLC | Not FDA Authorized | H |
Molecular Diagnostics, Christiana Care Health Systems | Not FDA Authorized | H |
Montefiore Medical Center | Not FDA Authorized | H |
Nanticoke Memorial Hospital Laboratory | Not FDA Authorized | H |
New York Presbyterian Hospital - Weill Cornell Medicine (NYPH-WCM) | Not FDA Authorized | H |
Next Bio-Research Services LLC | Not FDA Authorized | H |
NIPD Genetics Public Company Limited | Not FDA Authorized | H |
North Central Florida Neurodiagnostic Services DBA: NCF Diagnostics & DNA Technologies | Not FDA Authorized | H |
NxGen MDx | Not FDA Authorized | H |
NYU Langone Medical Center | Not FDA Authorized | H |
Oklahoma University Medicine Laboratory | Not FDA Authorized | H |
Opteo Laboratory, LLC | Not FDA Authorized | H |
Orlando Health | Not FDA Authorized | H |
Pathology Center, Nebraska Methodist Hospital | Not FDA Authorized | H |
Patriot Medical Laboratories LLC DBA CIAN Diagnostics | Not FDA Authorized | H |
Poplar Healthcare | Not FDA Authorized | H |
Primex Clinical Laboratories, Inc. | Not FDA Authorized | H |
Proteus Molecular and Clinical Lab LLC | Not FDA Authorized | H |
PTC Laboratories, Inc. | Not FDA Authorized | H |
RCA Laboratory Services LLC DBA GENETWORx | Not FDA Authorized | H |
Real Diagnostics Laboratory | Not FDA Authorized | H |
ResourcePath, LLC | Not FDA Authorized | H |
Saint Mary's Medical Center | Not FDA Authorized | H |
Sciteck Clinical Laboratory | Not FDA Authorized | H |
Sharp Copley Laboratory | Not FDA Authorized | H |
Specialty Drug Testing | Not FDA Authorized | H |
Sonic Reference Laboratory | Not FDA Authorized | H |
Tampa General Hospital | Not FDA Authorized | H |
Texas Children's Hospital Department of Pathology | Not FDA Authorized | H |
TGen North, Clinical Laboratory | Not FDA Authorized | H |
UCSF-Health | Not FDA Authorized | H |
UC Berkeley Innovative Genomic Institute | Not FDA Authorized | H |
University of Minnesota Genomics Center | Not FDA Authorized | H |
University of Washington | Not FDA Authorized | H |
WestPac Labs | Not FDA Authorized | H |
Wisconsin Diagnostic Laboratories | Not FDA Authorized | H |
Xymbio, LLC | Not FDA Authorized | H |
Yale Pathology Molecular Diagnostic Laboratory | Not FDA Authorized | H |
Virginia Tech Schiffert Health Center | Not FDA Authorized | H |
ASU Biodesign Clinical testing Laboratory, Center for Personalized Diagnostics | Not FDA Authorized | H |
Kashi Clinical Laboratories, Inc. | Not FDA Authorized | H |
DxTerity Diagnostics, Inc. | Not FDA Authorized | H |
Valley Medical and Wellness Laboratory | Not FDA Authorized | H |
Aperiomics Molecular Laboratory | Not FDA Authorized | H |
UniPath | Not FDA Authorized | H |
UCSC Molecular Diagnostic Lab | Not FDA Authorized | H |
Banner-University Medical Center Tucson | Not FDA Authorized | H |
Eurofins Clinical Molecular Testing Services, LLC | Not FDA Authorized | H |
Physicians Laboratory Services, Inc. | Not FDA Authorized | H |
Essentia Health East- SMDC Laboratory | Not FDA Authorized | H |
PacGenomics Lab | Not FDA Authorized | H |
Northside Hospital | Not FDA Authorized | H |
Paradigm Laboratories | Not FDA Authorized | H |
Acutis Diagnostics | Not FDA Authorized | H |
North Shore Medical Center Clinical Lab | Not FDA Authorized | H |
River Road Testing Laboratory | Not FDA Authorized | H |
AKESOgen | Not FDA Authorized | H |
AdvaGenix | Not FDA Authorized | H |
Danner Laboratory | Not FDA Authorized | H |
MD Labs | Not FDA Authorized | H |
ApolloMDx Labs | Not FDA Authorized | H |
Signal Diagnostics | Not FDA Authorized | H |
Women's Health Laboratory | Not FDA Authorized | H |
Lab Genomics LLC | Not FDA Authorized | H |
Pathlab Services Inc. | Not FDA Authorized | H |
Santa Clara Valley Medical Center Clinical Laboratory | Not FDA Authorized | H |
Rosalind Franklin University Clinical Immunology Laboratory | Not FDA Authorized | H |
Tribal Diagnostics, LLC | Not FDA Authorized | H |
BioReference Laboratories, Inc. | Not FDA Authorized | H |
Sun Clinical Laboratories | Not FDA Authorized | H |
CorePlus Servicios Clínicos y Patológicos, LLC | Not FDA Authorized | H |
FLO-MEDILAB SERVICES, LLC | Not FDA Authorized | H |
MedArbor Diagnostics | Not FDA Authorized | H |
Olin Health Center, Michigan State University | Not FDA Authorized | H |
George Washington University Hospital Laboratory | Not FDA Authorized | H |
NeoGenomics Laboratories, Inc. | Not FDA Authorized | H |
Sports Drug Testing Laboratory | Not FDA Authorized | H |
Genomic Expression | Not FDA Authorized | H |
Sunpath-MDL | Not FDA Authorized | H |
Ambry Genetics | Not FDA Authorized | H |
Cincinnati Children's Hospital Medical Center | Not FDA Authorized | H |
Tallahassee Memorial HealthCare | Not FDA Authorized | H |
Veritas Genetics | Not FDA Authorized | H |
Asante Rogue Regional Medical Center | Not FDA Authorized | H |
Southern Illinois Healthcare, Herrin Hospital | Not FDA Authorized | H |
Research Medical Center Laboratories | Not FDA Authorized | H |
Truman Medical Center | Not FDA Authorized | H |
University of Colorado School of Medicine Hospital | Not FDA Authorized | H |
Charles River Laboratories, Inc. Reno, Nevada | Not FDA Authorized | H |
Children's Hospital Los Angeles Clinical Virology Laboratory | Not FDA Authorized | H |
HFI Laboratory at Boston University dba Boston University Clinical Testing Laboratory | Not FDA Authorized | H |
University of Chicago Medical Center Main Clinical Laboratory | Not FDA Authorized | H |
Adventist Health Castle Laboratory | Not FDA Authorized | H |
OptimaLab, Inc. | Not FDA Authorized | H |
St. Joseph's Hospital and Medical Center | Not FDA Authorized | H |
Mayo Clinic Jacksonville Clinical Laboratory | Not FDA Authorized | H |
Alliance HealthCare System | Not FDA Authorized | H |
Ingenious Personalized Medicine | Not FDA Authorized | H |
Inno Diagnostics | Not FDA Authorized | H |
Columbia University Medical Center | Not FDA Authorized | H |
Transfusion Transmitted Viruses Lab NIH | Not FDA Authorized | H |
303 Diagnostics, LLC. | Not FDA Authorized | H |
Innovative Genomics LLC. d/b/a Innovative Gx Laboratories | Not FDA Authorized | H |
Premier Medical, Inc. dba Premier Medical Laboratory Services | Not FDA Authorized | H |
UofSC College of Pharmacy Diagnostic Genomics Laboratory | Not FDA Authorized | H |
Lucence Diagnostics Pte Ltd | Not FDA Authorized | H |
Elite Medical Laboratory Solutions LLC dba Diax Labs | Not FDA Authorized | H |
Access Dx Laboratory, LLC | Not FDA Authorized | H |
ACL Laboratories | Not FDA Authorized | H |
Ascension Columbia St. Mary's Milwaukee | Not FDA Authorized | H |
Atrium Health Core Laboratory | Not FDA Authorized | H |
Baptist Medical Center | Not FDA Authorized | H |
Capital Digestive Care, LLC., Laboratory Services | Not FDA Authorized | H |
Diagnostic Laboratory Services, Inc. (HI) | Not FDA Authorized | H |
IDL Acquisition Co., LLC DBA MDx Laboratory Services | Not FDA Authorized | H |
INOVA Core Research Lab | Not FDA Authorized | H |
Weill Cornell Medicine | Not FDA Authorized | H |
Wise Diagnostic Systems | Not FDA Authorized | H |
P4 Clinical LLC | Not FDA Authorized | H |
Physician STAT Lab Molecular | Not FDA Authorized | H |
Molecular Diagnostics Laboratory, Department of Pathology, Yale School of Medicine | Not FDA Authorized | H |
Histogenetics | Not FDA Authorized | H |
LynxDx | Not FDA Authorized | H |
Kai Medical Laboratory | Not FDA Authorized | H |
Advanced Diagnostic Laboratory, LLC | Not FDA Authorized | H |
SummerBio Labs | Not FDA Authorized | H |
Saint Luke's Hospital of Kansas City | Not FDA Authorized | H |
Sutter Health Shared Laboratory (SHSL) | Not FDA Authorized | H |
Machaon Diagnostics, Inc. | Not FDA Authorized | H |
Kaiser Santa Clara Laboratory | Not FDA Authorized | H |
New Hampshire Public Health Laboratories | Not FDA Authorized | H |
Ome Ventures, Inc. | Not FDA Authorized | H |
BioBridge Global (BBG) | Not FDA Authorized | H |
NeoVect Technologies, LLC | Not FDA Authorized | H |
Loma Linda University Medical Center Clinical Laboratory | Not FDA Authorized | H |
NOAH Associates | Not FDA Authorized | H |
Arctic Medical Laboratories | Not FDA Authorized | H |
Alliance Laboratories | Not FDA Authorized | H |
Symbiotica, Inc. | Not FDA Authorized | H |
RAS Medical Solutions | Not FDA Authorized | H |
Telomere Diagnostics Inc. | Not FDA Authorized | H |
Pioneer Hi-Bred International, Inc. | Not FDA Authorized | H |
MOgene LC | Not FDA Authorized | H |
Raazi Clinical Laboratory LLC | Not FDA Authorized | H |
Northwestern Medicine Diagnostic Molecular Lab | Not FDA Authorized | H |
University of Maryland Baltimore | Not FDA Authorized | H |
TAAG Genetics Corp | Not FDA Authorized | H |
QuickMed Diagnostic, LLC | 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 |
Nanjing Liming Bio-Products Co., Ltd., StrongStep® Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit | Not FDA Authorized | H |
DowGene Co., Ltd., Dow QuickFinderTM 2019-nCov Real-Time PCR Kit | 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 |
Merlin Biomedical (Xiamen) Co. Ltd., Novel Coronavirus (COVID-19) RT-PCR Kit | 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 |
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 |
---|---|---|
BioDiagnostic Inc. | Not FDA Authorized | H |
EDP Biotech Corporation | Not FDA Authorized | H |
Genalyte, Inc | Not FDA Authorized | H |
IMMYLabs | Not FDA Authorized | H |
University of Minnesota Advanced Research and Diagnostic Laboratory | Not FDA Authorized | H |
White Coat Sciences | Not FDA Authorized | H |
KSL Diagnostics | Not FDA Authorized | H |
Enzo Clinical Labs | Not FDA Authorized | H |
University of Arizona Genetics Core for Clinical Services | Not FDA Authorized | H |
Center for Cellular Therapy Medical University of South Carolina | Not FDA Authorized | H |
IGeneX Inc. | Not FDA Authorized | H |
LabCorp Center for Esoteric Testing | Not FDA Authorized | H |
OneBlood, Inc. | Not FDA Authorized | H |
Ethos Laboratories | Not FDA Authorized | H |
Stanford Health Care | Not FDA Authorized | H |
Mayo Clinic | Not FDA Authorized | H |
Exsera Biolabs at the University of Colorado Anschutz Medical Campus | Not FDA Authorized | H |
CQuentia NGS, LLC | Not FDA Authorized | H |
Symbiotica, Inc | Not FDA Authorized | H |
Brigham and Women's Hospital | Not FDA Authorized | H |
Allermetrix, Inc. | Not FDA Authorized | H |
Cincinnati Children's Hospital Medical Center | Not FDA Authorized | H |
Phosphorus Diagnostics LLC | Not FDA Authorized | H |
Pan Laboratories | Not FDA Authorized | H |
ProterixBio, Inc | Not FDA Authorized | H |
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 |
---|---|---|
Guangzhou Wondfo Biotech Co., Ltd. SARS-CoV-2 Antibody Test | Not FDA Authorized | H |
Boditech Med Inc AFIAS COVID-19 Ab serological tests | Not FDA Authorized | H |
Türklab Tibbi Malzemeler San. ve Tic. A.Ş. INFO SARS-CoV-2 IgM/IgG Ab Test | Not FDA Authorized | H |
Türklab Tibbi Malzemeler San. ve Tic. A.Ş. TOYO SARS-CoV-2 IgM/IgG Ab Test | Not FDA Authorized | H |
Qiagen GmbH Access Anti-SARS-CoV-2 Total Test | Not FDA Authorized | H |
LG Chem, Ltd., AdvanSure™ SARS-CoV-2 IgG(S1) ELISA | Not FDA Authorized | H |
LG Chem, Ltd AdvanSure™ SARS-CoV-2 IgG(RBD) ELISA | Not FDA Authorized | H |
Trinity Biotech USA Captia™ SARS-CoV-2 IgG 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.