HHS Publishes Notice Exempting Devices from Premarket Review in Final Days of Trump Administration

HHS Publishes Notice Exempting Devices from Premarket Review in Final Days of Trump Administration

February 2, 2021, Covington Alert

On January 15, the final Friday of the Trump administration, the Department of Health and Human Services (“HHS”) published in the Federal Register a notice permanently exempting or proposing to exempt 101 medical devices that previously required a premarket clearance under section 510(k) of the Food, Drug & Cosmetic Act (“FDCA”).  Under the notice, seven class I medical devices were immediately, permanently exempted from the 510(k) premarket review requirement, and eighty-three class II devices and one unclassified device were proposed to be permanently exempted from such requirement.  The notice is not affected by President Biden’s inauguration-day regulatory freeze that otherwise prevents Trump-era rules from going into effect after the transition because (1) the exemption of class 1 devices was effective prior to January 20, 2021, and (2) the proposal to exempt class II and unclassified devices was only a proposal, and further action is still required from FDA.