Docket Number:
FDA-2021-D-0603
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance provides performance criteria for denture base resins in support of the Safety and Performance Based Pathway. Under this framework, submitters (you) planning to submit a 510(k) using the Safety and Performance Based Pathway for denture base resins will have the option to use the performance criteria proposed in this draft guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.

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All written comments should be identified with this document's docket number: FDA-2021-D-0603.