FDA Releases Proposed List of 510(k) Exempt Class II Devices

By MedTech Intelligence Staff

The agency states this list of more than 1000 devices doesn’t have risks that warrant premarket notification.

FDA has compiled a document containing more than 1000 Class II devices that the agency is suggesting be exempt or partially exempt from 510(k) requirements. Listed in the Federal Register, these devices do not present risks that require premarket notification review in order to provide reasonable assurance of safety and effectiveness, according to FDA.

“Medical devices that are exempt from 510(k) are not exempt from other regulatory controls. All medical devices must be manufactured under current good manufacturing practice requirements, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA.” – FDA

The agency has published the notice and is requesting public comment, which ends on May 15, as part of the procedures established by the 21st Century Cures Act.

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