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. Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Orthopedic Fracture Fixation Plates - 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-2022-D-0552
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance provides performance criteria for Orthopedic Fracture Fixation Plates 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 Orthopedic Fracture Fixation Plates will have the option to use the performance criteria proposed in this 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-2022-D-0552.

 
Back to Top