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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.

 

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

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