为所有利益相关者提供一个明确的政策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.
具体而言，该指南草案适用于已根据《联邦食品，毒品和化妆品法》第564条（FD＆C法案）（美国法典360BB-3）第564条发布的设备（根据设备相关的COVID-19 EUA声明）。该指南草案不适用于FDA根据《 FD＆C法案》第564（g）（2）（2）（2）（b） - （c）条撤销EUA的设备，因为《 FD＆C法案》第564（c）条所规定的标准否更长的情况或因为其他情况使这种吊销适合保护公共卫生或安全。
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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FDA警告消费者伪造的共同测试套件 |
当PHE结束时，COVID-19 EUAS不会自动终止。FDA将在终止EUA之前180天在联邦公报上发布预订通知。
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The draft guidance is available athttps://www.regulations.gov或者https://www.fda.gov/regulatory-information/search-fda-guidance-documents。Electronic or written comments on the draft guidance must be submitted by March 23, 2022.
