To provide a clear policy for all stakeholders and FDA staff, the agency has issued the guidance to describe its general recommendations for this transition process with respect to devices issued EUAs during the COVID-19 PHE, including recommendations regarding submitting a marketing submission, as applicable, and taking other actions with respect to these devices.
Specifically, the draft guidance applies to devices that have been issued EUA under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3) on the basis of a device-related COVID-19 EUA declaration. The draft guidance does not apply to devices for which FDA has revoked the EUA under section 564(g)(2)(B)-(C) of the FD&C Act because the criteria under section 564(c) of the FD&C Act were no longer met or because other circumstances made such revocation appropriate to protect the public health or safety.
The FDA is concurrently issuing a companion guidance to describe its recommendations for transitioning devices that fall within enforcement policies issued during the COVID-19 PHE.
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COVID-19 EUAs will not automatically terminate when the PHE ends. The FDA will publish an advance termination notice in the Federal Register 180 days before it terminates an EUA.
Unlike EUAs, however, adopted emergency policies will automatically terminate the day the declared PHE ends. To create flexibility, the PHE Guidance offers a new phased approach to extend certain of the adopted emergency policies for 180 days after the declared PHE ends. Phase 1 will begin the day the PHE ends (implementation date), Phase 2 will begin 90 days after the implementation date, and Phase 3 will begin 180 days after the implementation date. The FDA will withdraw its emergency policies at the start of Phase 3 (withdrawal date). The FDA will recommend different compliance requirements for each phase in preparation for the withdrawal date. If the PHE ends before the final guidance is issued, the implementation date will be at least 45 days after the finalization of the guidance.
The draft guidance is available at https://www.regulations.gov or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Electronic or written comments on the draft guidance must be submitted by March 23, 2022.