The U.S. Food & Drug Administration (FDA) previously issued emergency use authorizations (EUA) and adopted emergency policies in response to the COVID-19 public health emergency (PHE) to facilitate the availability of key medical devices such as in vitro diagnostic tests, personal protective equipment, and ventilators.
To enable an “orderly and transparent transition” when the PHE ends, FDA recently released two nonbinding draft guidance documents addressing: (1) EUAs (EUA Guidance); and (2) medical devices falling under specific PHE policies (PHE Guidance). The FDA will issue final guidance documents following public comment.
Of note, COVID-19 EUAs will not automatically terminate when the PHE ends. FDA is statutorily authorized to issue EUAs under certain circumstances and must follow statutory guidelines to terminate EUAs. The EUA Guidance clarifies that the FDA will publish an advance termination notice in the Federal Register 180 days before it terminates an EUA (EUA termination date).
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. See List 1 for the PHE Guidance’s scope. 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. FDA will withdraw its emergency policies at the start of Phase 3 (withdrawal date). 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, FDA states that the implementation date will be at least 45 days after the finalization of the guidance.
FDA recognizes that it will take time for device manufacturers, healthcare facilities, providers, patients, and consumers to adjust to new policies post-PHE and seeks to avoid exacerbating product shortages and supply chain disruptions. The FDA invites comments now through March 23, 2022. Submit EUA Guidance comments here. Submit PHE Guidance comments here.
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