FDA Issues Sterilization Guidance for Cleared Devices

A Jan. 21 guidance seeks to ensure that manufacturers use adequate sterilization methods for cleared medical devices.

The guidance also tries to instruct industry about appropriate documentation and information the Food and Drug Administration requires for premarket review of established and novel sterilization processes.

Implementation of recommendations in the document will begin March 21, a Federal Register notice (81 Fed. Reg. 3,436) announcing the guidance said. At that time, the guidance will supersede one from August 2002 titled “Updated 510(k) Sterility Review Guidance K90-1,” the document said.

Webinar Planned.

A webinar is planned for Feb. 11 to discuss the guidance, ...