> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Orthopedic Implant Guide Guidance
- URL: https://www.fdaweb.com/orthopedic-implant-guide-guidance/
- Published: 2023-06-28T12:00:00.000Z
- Updated: 2026-09-14T18:41:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154782

FDA has published a draft guidance, *Patient-Matched Guides to Orthopedic Implants*, with recommendations on information that should be included in regulatory submissions for patient-matched guides to orthopedic implants. The [document](https://www.fda.gov/media/169792/download?ref=fdaweb.com) also has recommendations that manufacturers should consider when developing their design process for this device type.

“Patient-matched guides are intended to assist in the execution of a pre-surgical plan concurred upon by the patient’s healthcare professional to position an orthopedic implant in a way consistent with the implant’s indicated use,” the guidance says.

It contains an Introduction, Background, Scope, and Submission and Design Recommendations.