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GUIDANCE DOCUMENT

Conventional Foley Catheters - Performance Criteria for Safety and Performance Based Pathway Guidance for Industry and Food and Drug Administration Staff August 2020

Download the Final Guidance Document
Final
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and Performance Based Pathway for Foley catheters will have the option to use the performance criteria proposed in this draft guidance to support substantial equivalence, rather than a direct comparison of performance of the subject device to that of a predicate device.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-1651.

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