FDA Issues Two Draft Guidances 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 U.S. Food and Drug Administration (FDA) issued two draft guidances to identify performance criteria and testing methodologies for additional device types under the Safety and Performance Based Pathway: Note: These guidances are not for implementation at this time. Under this framework, submitters planning to submit a 510(k) for these devices will have the option to use the performance criteria proposed in these guidances, once finalized, 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 numbers below at www.regulations.gov. Submit comments on these draft guidances Both draft guidances will be open for public comments for 60 days at www.Regulations.gov. - Denture Base Resins – Performance Criteria for Safety and Performance Based Pathway under docket number FDA-2021-D-0603
- Facet Screw Systems – Performance Criteria for Safety and Performance Based Pathway under docket number FDA-2021-D-0604
Questions? If you have questions about these draft guidances, contact the contact the Division of Industry and Consumer Education. | 
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