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Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements - Draft Guidance for Industry and FDA Staff

A draft guidance titled, "Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements" has recently been posted.  This draft guidance describes the FDA’s intent to exempt certain Class II medical devices and certain Class I medical devices that are subject to the reserved criteria of section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 submission requirements. The FDA believes devices identified in section 4 of this guidance document are sufficiently well understood and do not present risks that require premarket notification (510(k)) review to assure their safety and effectiveness. For more information, please see: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM407292.pdf