What's Next For COVID-Era Emergency Use Medical Devices

By Joshua Oyster, Beth Weinman and Helen Ryan (January 19, 2022, 5:52 PM EST) -- In late December 2021, the U.S. Food and Drug Administration issued two draft guidance documents regarding unapproved medical devices that the FDA has allowed to be marketed during the COVID-19 pandemic: one details transition plans for devices issued emergency use authorizations, or EUAs, under Section 564 of the Federal Food Drug and Cosmetic Act;[1] the other addresses devices subject to the FDA's COVID-19-related enforcement policies.[2]...

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