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Specifically, the draft guidance applies to devices that have been issued EUA under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3) on the basis of a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 The draft guidance does not apply to devices for which FDA has revoked the EUA under section 564(g)(2)(B)-(C) of the FD&C Act because the criteria under section 564(c) of the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.
