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News and Press: Policy News

Final Guidance on Planned Exemption of Certain Devices

Thursday, July 16, 2015   (0 Comments)
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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.

The devices include certain anesthesiology, cardiovascular, general and plastic surgical, and neurological devices. “The FDA believes devices identified in . . . this guidance document are sufficiently well understood and do not require premarket notification (510(k)) to assure their safety and effectiveness.” Until a final rule on the issue is published, the FDA has announced that it does not plan to enforce compliance with 510(k) requirements for devices in the listed categories and does not expect manufacturers to submit 510(k) submissions for these devices.

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