U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Facet Screw Systems – Performance Criteria for Safety and Performance Based Pathway
  1. Search for FDA Guidance Documents

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Facet Screw Systems – Performance Criteria for Safety and Performance Based Pathway Draft Guidance for Industry and Food and Drug Administration Staff August 2021

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2021-D-0604
Issued by:
Guidance Issuing Office
Center 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This draft guidance provides performance criteria for facet screw systems in support of the Safety and Performance Based Pathway.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Performance Based Pathway for facet screw systems will have the option to use the performance criteria proposed in this draft guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.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

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.

Back to Top