Per the notice below, the United States Food and Drug Administration (FDA) has issued a final guidance on performance criteria for denture base resins.
FDA Issues Final Guidance on Performance Criteria for Safety and Performance Based Pathway
In support of its goal to strengthen and modernize the 510(k) medical device program, the FDA issued final guidance to identify performance criteria and testing methodologies for additional device types under the Safety and Performance Based Pathway:
Under this framework, submitters planning to submit a 510(k) for denture base resins will have the option to use the performance criteria identified in the 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 industry and stakeholders to continue providing the FDA with recommendations for additional types of devices that would benefit from inclusion in future guidances regarding performance criteria and testing methodologies for the Safety and Performance Based Pathway using the docket number FDA-2018-D-1387 at www.regulations.gov.
If you have questions about the final guidance, contact the Division of Industry and Consumer Education