GUIDANCE DOCUMENT
Facet Screw Systems – Performance Criteria for Safety and Performance Based Pathway Draft Guidance for Industry and Food and Drug Administration Staff August 2021
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2021-D-0604
- Issued by:
-
Guidance Issuing OfficeCenter for Devices and Radiological Health
This draft guidance provides performance criteria for facet screw systems in support of the Safety and Performance Based Pathway. Under this framework, submitters (you) 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Performance Based Pathway for facet screw systems will have the option to use the performance criteria proposed in this draft guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.
Submit Comments
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.