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In support of our goal to strengthen and modernize the 510(k) medical device program, the U.S. Food and Drug Administration (FDA) issued the final guidance: Endosseous Dental Implants and Endosseous Dental Implant Abutments - Performance Criteria for Safety and Performance Based Pathway.
Under the Safety and Performance Based Pathway, medical device manufacturers planning to submit a 510(k) for these devices will have the option to use the performance criteria identified in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.
The FDA strongly encourages the medical device industry to continue to provide the FDA with recommendations for additional types of devices that would benefit from inclusion in future guidances about performance criteria and testing methodologies for the Safety and Performance Based Pathway using the docket number FDA-2018-D-1387 at Regulations.gov.
Questions?
If you have questions about this guidance, contact the Division of Industry and Consumer Education.
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