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GUIDANCE DOCUMENT

Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway Guidance for Industry and Food and Drug Administration Staff December 2020

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2019-D-1647
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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.

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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-2019-D-1647.

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