FDA's Final Guidance on Planned Device Exemption

Thursday, July 16, 2015

Source: Mich Bio

The FDA released a final guidance recently entitled, "Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements." This guidance describes the agency’s intent to exempt certain unclassified medical devices, certain Class II medical devices, and certain Class I medical devices that are subject to the reserved criteria of section 510(l) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 360(l), from premarket notification requirements.

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