Docket Number:
FDA-2019-D-1651
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This final guidance provides performance criteria for conventional Foley catheters in support of the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for Foley catheters will have the option to use the performance criteria proposed in this draft guidance to support substantial equivalence, rather than a direct comparison of performance of the subject device to that of a predicate device.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-2019-D-1651.