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GUIDANCE DOCUMENT

Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions Guidance for Industry and Food and Drug Administration Staff November 2024

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2023-D-0488
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health, Office of Product Evaluation and Quality, Office of Health Technology VI - Orthopedic Devices

This guidance document provides the FDA’s recommendations on information to support premarket submissions for orthopedic non-spinal bone plates, screws, and washers. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of orthopedic non-spinal bone plate, screw, and washer submissions.

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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-2023-D-0488.

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