Health Law Daily Wrap Up, MEDICAL DEVICES—FDA GUIDANCE NOTICES: FDA issues guidance on dental implants, (Oct 15, 2024)

By WK Editorial Staff

The FDA announced the availability of a final guidance entitled “Endosseous Dental Implants and Endosseous Dental Implant Abutments—Performance Criteria for Safety and Performance Based Pathway.”

The device-specific guidance identified in the notice was developed in accordance with the finalized guidance entitled “Safety and Performance Based Pathway.” This guidance has been implemented without prior comment, but it remains subject to comment in accordance with the FDA’s good guidance practices (Notice, 89 Fed. Reg. 83019 (Oct. 15, 2024)).

Dates. The announcement of the guidance was published in the Federal Register on October 15, 2024.

FederalRegisterIssuances: FDAGuidanceNotices FDCActNews MDeviceNews SafetyNews