FDA Reverses HHS Action Exempting Devices from 510k Premarket Requirement
Tuesday, April 20, 2021 On April 16, 2021, the Food and Drug Administration (FDA) published twin notices in the Federal Register effectively reversing a move by the Trump administration Department of Health and Human Services (HHS) on January 15, 2021 purporting to exempt 91 medical device types from the premarket notification requirement under Section 510(k) of the Federal Food, Drug, and Cosmetic Act. HHS’s actions on January 15, signed by then-HHS Secretary Alex Azar, sought to make permanent FDA’s grant of temporary enforcement discretion for the 91 device types for the...
Source: natlawreview.com