The US Food and Drug Administration announced that it has withdrawn its temporary policies related to the COVID-19 pandemic because they are no longer necessary. The agency released this news after twice previously announcing its transition plans to return to full agency operations. The withdrawal date is July 7, 2022, for all COVID-era enforcement policies.
The FDA has “continually assessed the needs and circumstances related to these temporary policies, and as relevant needs and circumstances evolved, the agency made updates and modifications.” Now the agency has announced a full withdrawal of COVID-era guidance and has issued a Q&A for medical device and in vitro diagnostic (IVD) device manufacturers to answer questions on which processes are affected…
