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.