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GUIDANCE DOCUMENT

Facet Screw Systems - Performance Criteria for Safety and Performance Based Pathway Guidance for Industry and Food and Drug Administration Staff April 2022

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2021-D-0604
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance document provides the FDA's recommendations on performance criteria to support premarket submissions for facet screw systems in the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for facet screw systems will have the option to use the performance criteria proposed in this final guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device. The recommendations are intended to promote consistency and facilitate efficient review of facet screw systems submissions.

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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-2021-D-0604.

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