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  7. In Vitro Diagnostics EUAs - IVDs for Management of COVID-19 Patients
  1. COVID-19 Emergency Use Authorizations for Medical Devices

In Vitro Diagnostics EUAs - IVDs for Management of COVID-19 Patients

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

This table includes information about authorized in vitro diagnostic devices that may be used in the management of patients with COVID-19 that have been authorized individually. These EUAs have been issued for each individual devices with certain conditions of authorization required of the manufacturer and authorized laboratories.

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 IL-6 Diagnostic Tests are assigned the QLC product code. Authorized sodium citrate blood specimen collection tubes are assigned the QPW 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)
06/02/2020 Roche Diagnostics Elecsys IL-6
06/02/2020		 Immunoassay-IL-6 H, M HCP, Patients, IFU None None
10/01/2020 Beckman Coulter, Inc. Access IL-6
10/01/2020		 One-step immunoenzymatic ("sandwich") assay, IL-6 H, M HCP, Patients, IFU None None
12/18/2020 Siemens Healthcare Diagnostics Inc. ADVIA Centaur IL6 assay
12/18/2020		 One-step Direct Chemiluminescent Immunoassay H, M HCP, Patients, IFU 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.

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