Issue Date: May 7, 2026
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, Orthopedic
Status: Final
Patient-Matched Guides for Orthopedic Implants: Guidance for Industry and Food and Drug Administration Staff
This guidance document provides the FDA’s recommendations on information to support premarket submissions for patient-matched guides for orthopedic implants. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of submissions for patient-matched guides for orthopedic implants. This document also provides recommendations that manufacturers should consider when developing their design process for these device types.
Download the Guidance Document
