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Guidance Issuing OfficeCenter 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.
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:
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.