U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Medical Devices
  3. Medical Device Safety
  4. Emergency Situations (Medical Devices)
  5. Emergency Use Authorizations for Medical Devices
  6. COVID-19 Emergency Use Authorizations for Medical Devices
  7. In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2
  1. COVID-19 Emergency Use Authorizations for Medical Devices

In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2

March 24, 2023 - The FDA has finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). The guidances outline the FDA's general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDA's recommendations for: 

  • Developing a transition implementation plan, 
  • Submitting a marketing submission, and 
  • Taking other actions with respect to these devices. 

The FDA encourages stakeholders to review the two final guidances, view the webinar, and reach out to the FDA if they have questions or concerns. In particular, for manufacturers planning to seek marketing authorization for their devices, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances. 

Additional Resources: 

In Vitro Diagnostic EUAs: Overview and Templates

On This Page:

Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2

The table below includes information about authorized SARS-CoV-2 antigen diagnostic tests that have been authorized individually. These emergency use authorizations (EUAs) have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories. Test attributes are listed in the "Attributes" column. For example, tests authorized for the screening of asymptomatic individuals without known exposure are listed with "screening" in the attribute column; pooling, multi-analyte, saliva, home collection, and home testing are similarly listed. Tests available without a prescription include the attribute "DTC" (for direct-to-consumer home collection tests) or "OTC" (for over-the-counter at-home tests).

For information on test EUAs that have been revoked see Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD).

In addition to COVID-19 tests issued EUAs, there are antigen SARS-CoV-2 diagnostic tests that have been authorized through traditional premarket review pathways.

Tests with "single target" in the attribute column are:

  • designed to detect only one antigen target, currently either a section of the spike protein or a section of the nucleocapsid protein;
  • more susceptible to changes in performance due to viral mutations, meaning they are more likely to fail to detect new variants.

Tests with "multiple targets" in the attribute column are:

  • designed to detect more than one section of the proteins that make up SARS-CoV-2;
  • more likely to continue to perform as labeled as new variants emerge.

To see additional authorization documents, such as letters granting EUA amendments or revisions, and a list of other brand names authorized under a specific EUA, select the plus (+) button beside the "Date EUA Issued or Last Updated" for each EUA.

Authorized EUA devices in the table below for SARS-CoV-2 antigen diagnostic tests are assigned the QKP product code. Antigen multi-analyte respiratory panel tests authorized in the table below are assigned the QMN product code.

Date EUA Issued or Last Updated Entity Diagnostic (Most Recent Letter of Authorization) and Date EUA Originally Issued Attributes Authorized Setting(s)1 Authorization Documents2 Other Documents Other Brand Name(s)
02/22/2023 Mologic, Inc. COVI-Go SARS-CoV-2 Ag Self-Test
02/22/2023		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test)

None

None
06/16/2023 PHASE Scientific International, Ltd. INDICAID COVID-19 Rapid Antigen At-Home Test
03/16/2022		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None
12/11/2023 SD Biosensor, Inc. Pilot COVID-19 At-Home Test
12/24/2021		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target, Telehealth Proctor Supervised (optional) Home, H, M, W HCP, IFU, IFU (Home Test) None
08/24/2023 iHealth Labs, Inc. iHealth COVID-19 Antigen Rapid Test
11/05/2021		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target, Telehealth Proctor Supervised (optional) Home, H, M, W HCP, IFU, IFU (Home Test) GoToKnow COVID-19 Antigen Rapid Test
03/15/2023 ACON Laboratories, Inc Flowflex COVID-19 Antigen Home Test
10/04/2021		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) On/Go One COVID-19 Antigen Home Test
11/15/2023 SEKISUI Diagnostics, LLC. OSOM COVID-19 Antigen Rapid Test 09/24/2021 Lateral Flow, Visual Read, Serial Screening, Single Target H, M, W HCP, Patients, IFU None
02/27/2023 Quidel Corporation Sofia SARS Antigen FIA
05/08/2020		 Lateral Flow, Fluorescence, Instrument Read, Serial Screening, Single Target H, M, W HCP, Patients, IFU  None
03/21/2023 Becton, Dickinson and Company (BD) BD Veritor System for Rapid Detection of SARS-CoV-2
07/02/2020		 Chromatographic Digital Immunoassay, Instrument Read, Serial Screening, Single Target H, M, W HCP, Patients, IFU None
08/15/2023 LumiraDx UK Ltd. LumiraDx SARS-CoV-2 Ag Test
08/18/2020		 Microfluidic Immunofluorescence Assay, Instrument Read, Serial Screening, Single Target H, M, W HCP, Patients, IFU  None
01/13/2023 Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Ag Card
08/26/2020		 Lateral Flow, Visual Read, Single Target, Serial Screening H, M, W HCP, Patients, IFU  None
08/08/2023 Quidel Corporation Sofia 2 Flu + SARS Antigen FIA
10/02/2020		 Lateral Flow, Fluorescence, Instrument Read, Multi-Analyte, Single Target H, M, W HCP, Patients, IFU  None
01/17/2023 Access Bio, Inc. CareStart COVID-19 Antigen test
10/08/2020		 Lateral Flow, Visual Read, Serial Screening, Single Target H, M, W HCP, Patients, IFU 

None
02/16/2023 Ellume Limited Ellume COVID-19 Home Test
12/15/2020		 Lateral Flow, Fluorescence, Instrument Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test), FAQ None
04/10/2023 Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Ag Card Home Test
12/16/2020		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Telehealth Proctor Supervised, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None
04/04/2023 Quidel Corporation QuickVue SARS Antigen Test
12/18/2020		 Lateral Flow, Visual Read, Serial Screening, Single Target H, M, W HCP, Patients, IFU None
03/01/2023 Ortho Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack
01/11/2021		 Chemiluminescence Immunoassay, Instrument Read, Single Target H, M HCP, Patients, IFU None
05/12/2023 Princeton BioMeditech Corp. Status COVID-19/Flu A&B
02/04/2021		 Lateral Flow, Visual Read, Multi-analyte, Single Target H, M, W HCP, Patients, IFU None
03/30/2023 Quidel Corporation QuickVue At-Home COVID-19 Test
03/01/2021		 Lateral Flow, Visual Read, Prescription Home Testing, Single Target Home, H, M, W HCP, Patients, IFU, IFU (Home Test)  None
05/12/2023 Becton, Dickinson and Company (BD) BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B
03/24/2021		 Chromatographic Digital Immunoassay, Instrument Read, Multi-analyte, Single Target H, M, W HCP, Patients, IFU  None
02/17/2023 Quidel Corporation QuickVue At-Home OTC COVID-19 Test
03/31/2021		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) 
  • CVS Health At Home COVID-19 Test Kit
  • Walgreens At-Home COVID-19 Test Kit
11/21/2023 Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Antigen Self Test
03/31/2021		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None
04/21/2023 DiaSorin, Inc. LIAISON SARS-CoV-2 Ag
03/26/2021		 CLIA, Single Target H, M HCP, Patients, IFU  None
05/03/2023 Qorvo Biotechnologies, LLC. Omnia SARS-CoV-2 Antigen Test
04/13/2021		 Bulk Acoustic Wave (BAW) Biosensor, Instrument Read, Serial Screening, Single Target H, M, W HCP, Patients, IFU None
12/23/2022 InBios International, Inc. SCoV-2 Ag Detect Rapid Test
05/06/2021		 Lateral Flow, Visual Read, Serial Screening, Single Target H, M, W HCP, Patients, IFU None
03/29/2023 Salofa Oy Sienna-Clarity COVID-19 Antigen Rapid Test Cassette
05/20/2021		 Lateral Flow, Visual Read, Single Target H, M, W HCP, Patients, IFU 
  • Sienna COVID-19 Antigen Rapid Test Cassette
  • Clarity COVID-19 Antigen Rapid Test Cassette
  • OVIOS COVID-19 Antigen Rapid Test Cassette
  • Spring Health COVID-19 Antigen Rapid Test
  • Salocor COVID-19 Antigen Rapid Test Cassette
09/26/2023 OraSure Technologies, Inc. InteliSwab COVID-19 Rapid Test Rx
06/04/2021		 Lateral Flow, Visual Read, Prescription Home Testing, Single Target Home, H, M, W HCP, IFU, IFU (Home Test)  None
09/24/2024 OraSure Technologies, Inc. InteliSwab COVID-19 Rapid Test
06/04/2021		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening , Single Target Home, H, M, W HCP, IFU, IFU (Home Test)  None
09/26/2023 OraSure Technologies, Inc. InteliSwab COVID-19 Rapid Test Pro
06/04/2021		 Lateral Flow, Visual Read, Serial Screening , Single Target H, M, W HCP, Patients, IFU  None
02/01/2023 Ellume Limited ellume.lab COVID Antigen Test
07/08/2021		 Lateral Flow, Fluorescence, Instrument Read, Single Target H, M, W HCP, Patients, IFU None
02/21/2023 GenBody Inc. GenBody COVID-19 Ag
07/13/2021		 Lateral Flow, Visual Read, Serial Screening, Single Target H, M, W HCP, Patients, IFU None
06/16/2023 PHASE Scientific International, Ltd. INDICAID COVID-19 Rapid Antigen Test
07/28/2021		 Lateral Flow, Visual Read, Serial Screening, Single Target H, M, W HCP, Patients, IFU None
03/14/2023 Access Bio, Inc. CareStart COVID-19 Antigen Home Test
08/02/2021		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) On/Go COVID-19 Antigen Self-Test
05/18/2023 QIAGEN GmbH QIAreach SARS-CoV-2 Antigen
08/05/2021		 Digital Lateral Flow, Fluorescence, Instrument Read, Single Target H, M HCP, Patients, IFU None
01/06/2023 InBios International Inc. SCoV-2 Ag Detect Rapid Self-Test
11/22/2021		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None
12/15/2022 Nano-Ditech Corp. Nano-Check COVID-19 Antigen Test
12/06/2021		 Lateral Flow, Visual Read, Serial Screening, Single Target H, M, W HCP, Patients, IFU None
02/17/2023 Siemens Healthineers CLINITEST Rapid COVID-19 Antigen Self-Test
12/29/2021		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None
02/01/2024 iHealth Labs, Inc. iHealth COVID-19 Antigen Rapid Test Pro
01/14/2022		 Lateral Flow, Visual Read, Serial Screening, Single Target H, M, W HCP, Patients, IFU None
07/08/2024 Maxim Biomedical, Inc. MaximBio ClearDetect COVID-19 Antigen Home Test
01/19/2022		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None
02/24/2023 Oceanit Foundry LLC ASSURE-100 Rapid COVID-19 Test
02/28/2022		 Lateral Flow, Visual Read, Single Target H, M, W HCP, Patients, IFU None
05/03/2023 Siemens Healthcare Diagnostics, Inc. Atellica IM SARS-CoV-2 Antigen (CoV2Ag)
03/11/2022		 CLIA, Single Target H, M HCP, Patients, IFU None
05/03/2023 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag)
03/11/2022		 CLIA, Single Target H, M HCP, Patients, IFU None
09/26/2023 OSANG LLC OHC COVID-19 Antigen Self Test 04/06/2022 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test)

QuickFinder COVID-19 Antigen Self Test
01/23/2024 Xiamen Boson Biotech Co., Ltd. Rapid SARS-CoV-2 Antigen Test Card 04/06/2022 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None
02/21/2023 Watmind USA Speedy Swab Rapid COVID-19 Antigen Self-Test
07/08/2022		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None
07/10/2024 Genabio Diagnostics Inc. Genabio COVID-19 Rapid Self-Test Kit
07/08/2022		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None
06/09/2023 SEKISUI Diagnostics, LLC. OSOM COVID-19 Antigen Home Test
11/17/2022		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None None
04/13/2023 Beijing Hotgen Biotech Co., Ltd. Hotgen COVID-19 Antigen Home Test
11/17/2022		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None
03/16/2023 CorDX, Inc. CorDx COVID-19 Ag Test
11/21/2022		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None
11/21/2022 Azure Biotech Inc. Fastep COVID-19 Antigen Home Test
11/21/2022		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None None
12/06/2022 ACON Laboratories, Inc. Flowflex COVID-19 Antigen Rapid Test
12/06/2022		 Lateral Flow, Visual Read, Serial Screening, Single Target H, M, W HCP, Patients, IFU None None
04/30/2024 CTK Biotech, Inc. ImmuView COVID-19 Antigen Home Test 
12/20/2022		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None
12/22/2022 Oceanit Foundry LLC ASSURE-100 Rapid COVID-19 Home Test
12/22/2022		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None None
07/01/2024 Advin Biotech Inc. Advin COVID-19 Antigen Test @Home 12/22/2022 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None
02/17/2023 GenBody Inc. GenBody COVID-19 Ag Home Test
02/17/2023		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None None
09/20/2023 Biosynchronicity Corporation C-Sync COVID-19 Antigen Test 03/24/2023 Lateral Flow, Visual Read, Serial Screening, Multiple Targets H, M, W HCP, Patient, IFU None
04/14/2023 Azure Biotech, Inc. Azure FaStep® COVID-19 Antigen Pen Home Test 
04/14/2023		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None None
06/28/2023 Princeton BioMeditech Corp. Status COVID-19 Antigen Rapid Test for Home Use
04/24/2023		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None
05/12/2023 Nano-Ditech Corporation Nano-Check COVID-19 Antigen At-Home Test
05/12/2023		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None None
09/20/2023 BioTeke USA, LLC Bio-Self COVID-19 Antigen Home Test
05/22/2023		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None
07/17/2023 Immunostics Inc. Swab-N-Go Home Test COVID-19 Ag 07/17/2023 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None None
10/23/2024 Princeton BioMeditech Corp. ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Test
09/08/2023		 Lateral Flow, Visual Read, Multi-analyte, Single Target H, M, W HCP, Patient, IFU  None
09/12/2024 SD Biosensor, Inc. STANDARD Q COVID-19 Ag Test 2.0
09/29/2023		 Lateral Flow, Visual Read, Serial Screening, Single Target H, M, W HCP, Patients, IFU None
09/04/2024 SEKISUI Diagnostics, LLC OSOM Flu SARS-CoV-2 Combo Test 
02/29/2024		 Lateral Flow, Visual Read, Multi-analyte, Single Target H, M, W HCP, Patients, IFU None
09/04/2024 SEKISUI Diagnostics, LLC OSOM Flu SARS-CoV-2 Combo Home Test
2/29/2024		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Multi-analyte, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None
10/18/2024 OSANG LLC OHC COVID-19/Flu Antigen Test Pro 03/21/2024 Lateral Flow, Visual Read, Multi-analyte, Single Target H, M, W HCP, Patients, IFU None
09/26/2024 CorDx, Inc. CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test
03/21/2024		 Lateral Flow, Visual Read, Multi-analyte, Single Target H, M, W HCP, Patients, IFU None
10/18/2024 OSANG LLC QuickFinder COVID-19/Flu Antigen Self Test
04/03/2024		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Multi-analyte, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None
09/26/2024 CorDx, Inc. CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test
04/05/2024		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Multi-analyte, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None
07/02/2024 Wondfo USA Co., Ltd. WELLlife COVID-19 / Influenza A&B Test
04/19/2024		 Lateral Flow, Visual Read, Multi-analyte, Single Target H, M, W HCP, Patients, IFU None
07/02/2024 Wondfo USA Co., Ltd WELLlife COVID-19 / Influenza A&B Home Test
04/30/2024		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Multi-analyte, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None
10/09/2024 iHealth Labs, Inc. iHealth COVID-19/Flu A&B Rapid Test
05/07/2024		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Multi-analyte, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None
05/08/2024 Watmind USA Speedy Swab Rapid COVID-19 + Flu A&B Antigen Test
05/08/2024		 Lateral Flow, Visual Read, Multi-analyte, Single Target H, M, W HCP, Patients, IFU None None
09/12/2024 iHealth Labs, Inc. iHealth COVID-19/Flu A&B Rapid Test Pro
05/31/2024		 Lateral Flow, Visual Read, Multi-analyte, Single Target H, M, W HCP, Patients, IFU None
09/27/2024 Healgen Scientific, LLC Healgen COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)
06/10/2024		 Lateral Flow, Visual Read, Multi-analyte, Single Target H, M, W HCP, Patients, IFU None
05/24/2024 Watmind USA Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test
05/24/2024		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Multi-analyte, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None None
11/18/2024 Nano-Ditech Corporation Nano-Check Influenza+COVID-19 Dual Test
07/08/2024		 Lateral Flow, Visual Read, Multi-analyte, Single Target H, M, W HCP, Patients, IFU None
07/23/2024 ACON Laboratories, Inc. Flowflex Plus COVID-19 and Flu A/B Home Test
07/23/2024		 Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Multi-analyte, Single Target Home, H, M, W HCP, IFU, IFU (Home Test) None None

1 Authorized settings 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.

2 Authorization Documents include the Healthcare Provider (HCP) and Patient Fact Sheets and either the Manufacture Instructions/Package Insert (abbreviated to IFU) or the EUA Summary.

Revision Concerning Viral Mutations

On September 23, 2021, the FDA revised the EUAs of certain molecular, antigen, and serology tests to establish additional Conditions of Authorization in response to the continued emergence of new variants of SARS-CoV-2. The revision requires test developers to update their authorized labeling and evaluate the impact of SARS-CoV-2 viral mutations on their test’s performance as outlined in the letter. This revision is effective as of September 23, 2021 for all EUAs that are within the scope of the revision. This revision does not apply to EUAs for authorized IL-6 assays or standalone specimen collection devices and does not apply to EUAs that include substantially equivalent viral mutation conditions of authorization.

The FDA has determined that establishing additional conditions is necessary to mitigate the potential risk of false negative results due to either decreased sensitivity or non-reactivity associated with SARS-CoV-2 viral mutations. As set forth in the September 23, 2021 letter, developers of authorized tests that are within the scope of the revision are now required to routinely monitor emerging viral mutations and their potential impact on the performance of the authorized SARS-CoV-2 test(s). If potential impacts are identified, the EUA holder must communicate with the FDA and end users about the potential risk that presence of the mutations may have on test performance. The revision also required the EUA holder to update their authorized labeling consistent with the revision letter and submit the labeling to the FDA within 3 months of September 23, 2021. By taking these steps, the FDA and the test developer can quickly act in response to the potential risks identified and, when applicable, share the findings on SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests.

Viral Mutation Revision Letter – September 23, 2021

Antigen EUA Revisions for Serial (Repeat) Testing

On November 1, 2022, the FDA revised the authorized uses and required updates to product labeling regarding repeat, or serial, testing, for all currently authorized SARS-CoV-2 antigen tests.  The revised Letter of Authorization establishes one additional Condition of Authorization and also eliminates one Condition of Authorization that is no longer needed.

This action is in response to available data about the performance of COVID-19 antigen tests showing that repeat testing after a negative COVID-19 antigen test result increases the chance of an accurate result in people with and without symptoms and could help prevent people from unknowingly spreading the SARS-CoV-2 virus to others. The FDA communicated recommendations consistent with this revision in the August 11, 2022, Safety Communication: At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative. 

The November 1, 2022 revision requires test developers in the scope of the revision to take certain actions, including submitting a supplemental EUA request to the FDA with updated labeling to reflect the revised authorized uses, as follows:

  • Where a test was previously authorized for testing of symptomatic individuals (for example, within the first [number specific to each test] days of symptom onset), the test is now authorized for use at least twice over three days with at least 48 hours between tests.
  • Where a test was previously authorized for testing of asymptomatic individuals (for example, individuals without symptoms or other epidemiological reasons to suspect COVID-19), the test is now authorized for use at least three times over five days with at least 48 hours between tests. 

Repeat Testing Revision Letter - November 1, 2022 

Back to Top