Facet Screw Systems – Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

Issue Date: April 13, 2022
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k)
Status: Final

Facet Screw Systems – Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

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.

Download the Guidance Document