Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

Issue Date: December 11, 2020
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Orthopedic
Status: Final

Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

This guidance provides performance criteria for spinal plating 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 spinal plating systems 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. For the current edition of the FDA-recognized consensus standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database . For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.

Download the Guidance Document