In Vitro Diagnostics EUAs - Other 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:
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)
- Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - April 18, 2023
In Vitro Diagnostic EUAs: Overview and Templates
On This Page:
- Individual EUAs for Diagnostic Breath Tests for SARS-CoV-2
- Individual EUAs for Genotyping Tests for SARS-CoV-2
Individual EUAs for Diagnostic Breath Tests for SARS-CoV-2
This table includes information about authorized SARS-CoV-2 diagnostic tests that analyze breath samples and have been authorized individually. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and the settings authorized to use the EUA product. 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.
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 breath tests for the detection of volatile organic compounds associated with SARS-CoV-2 infection are assigned the QSH 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 Brand Name(s) |
---|---|---|---|---|---|---|
04/14/2022 | InspectIR Systems LLC | InspectIR COVID-19 Breathalyzer 04/14/2022 |
Rapid gas chromatography-mass spectrometry (GC-MS), Five Volatile Organic Compounds (VOCs), Screening | Near Patient/Point-of-Care | HCP, Patients, IFU | None |
1 Authorized settings noted as 'Near Patient/Point-of-Care' include environments where the patient specimen is both collected and analyzed and the test is performed by a qualified, trained operator under the supervision of a healthcare provider licensed or authorized by state law to prescribe tests.
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.
Individual EUAs for Genotyping Tests for SARS-CoV-2
This table includes information about authorized SARS-CoV-2 genotyping tests that have been authorized for the identification and differentiation of SARS-CoV-2 Phylogenetic Assignment of Named Global Outbreak (PANGO) lineages and/or for the identification of specific SARS-CoV-2 mutations. These EUAs have been issued for each individual test with certain conditions of authorization, including those required of the manufacturer, and the settings authorized to use the EUA product. Test attributes are listed in the "Attributes" column.
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 SARS-CoV-2 genotyping tests are assigned the QTA 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) |
---|---|---|---|---|---|---|---|
12/06/2023 | Laboratory Corporation of America (Labcorp) | Clear Dx SARS-CoV-2 WGS v3.0 Test 08/01/2023 |
Next Generation Sequencing (NGS), PANGO lineage | H | None | ||
06/10/2022 | Laboratory Corporation of America (Labcorp) | Labcorp VirSeq SARS-CoV-2 NGS Test 06/10/2022 |
Next Generation Sequencing (NGS), PANGO lineage | H | HCP, Patients, EUA Summary | None | None |
1Authorized 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.