- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
This draft guidance document provides the FDA’s recommendations on information to support premarket submissions for patient-matched guides to orthopedic implants. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of submissions for patient-matched guides to orthopedic implants. This document also provides recommendations that manufacturers should consider when developing their design process for these device types.
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:
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-2370.