UPDATE: Trump Administration’s Midnight Rulemaking to Exempt Certain Class I and II Devices from 510(k) Requirement Rescinded

Published date26 April 2021
Subject MatterMedical Devices,FDA,Life Sciences,510(k) RTA,Regulatory Reform,FDA Approval,Pharmaceutical Industry,Trump Administration,Department of Health and Human Services (HHS),Biden Administration
AuthorMichele Buenafe,Maria Kalousi-Tatum,Dennis Gucciardo
Law FirmMorgan Lewis

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