Health Law Daily Wrap Up, MEDICAL DEVICES—FDA GUIDANCE NOTICES: FDA issues four dental device-specific guidance documents, (Oct 2, 2024)

By WK Editorial Staff

The FDA announced the availability of four final device-specific guidance documents for the Safety and Performance Based Pathway.

Specifically, the FDA released “Air Powered Dental Handpieces and Air Motors—Performance Criteria for Safety and Performance Based Pathway,” “Dental Ceramics—Performance Criteria for Safety and Performance Based Pathway,” “Dental Impression Materials—Performance Criteria for Safety and Performance Based Pathway,” and “Dental Cements—Performance Criteria for Safety and Performance Based Pathway.” The device-specific guidances identified in the notice were developed in accordance with the finalized guidance entitled “Safety and Performance Based Pathway” (Notice 89 Fed. Reg. 79615 (Sept. 30, 2024)).

Dates. The announcement of the guidances was published in the Federal Register on September 30, 2024.

FederalRegisterIssuances: FDAGuidanceNotices FDCActNews MDeviceNews