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

A guidance has been posted titled, “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements - Guidance for Industry and Food and Drug Administration Staff.”

This guidance describes the Food and Drug Administration’s (FDA) 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. The FDA believes devices identified in section IV of this guidance document are sufficiently well understood and do not require premarket notification (510(k)) to assure their safety and effectiveness. FDA intends to propose exempting these devices from premarket notification requirements pursuant to the criteria at sections 510(l) and 510(m) of the FD&C Act, subject to limitations on exemption criteria found in 21 CFR 868.9, 21 CFR 870.9, 21 CFR 872.9, 21 CFR 874.9, 21 CFR 876.9, 21 CFR 878.9, 21 CFR 880.9, 21 CFR 882.9, 21 CFR 884.9, 21 CFR 886.9, and 21 CFR 890.9. Notice of such a proposal would be provided in the Federal Register. Until the publication of a final rule or order exempting these devices from 510(k), FDA does not intend to enforce compliance with 510(k) requirements for these devices. FDA does not expect manufacturers to submit 510(k)s for these devices during this time period.

To view the Guidance, please see:
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM407292.pdf.