Endosseous Dental Implants and Endosseous Dental Implant Abutments-Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing 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 this 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 Agency's good guidance practices.