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.

 


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If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
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Rockville, MD 20852

All written comments should be identified with this document’s docket number: FDA-2022-D-0552.