CDRH Industry: Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements - Guidance for Industry and FDA Staff

The final guidance entitled, "Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements" has recently been posted.  This guidance describes the FDA'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.