Rules and Regulations. Notice of availability

Agency: Food and Drug Administration, HHS
Action: Notice of availability
Citation: FR Doc. 2026-09023 · Docket No. FDA-2023-D-2370

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled “Patient-Matched Guides for Orthopedic Implants.” This guidance document provides recommendations regarding information that should be included in regulatory submissions for patient-matched guides for orthopedic implants. This guidance also provides recommendations that manufacturers should consider when developing their design process for these device types. This guidance is intended to promote clarity and transparency as to expectations regarding submission recommendations for orthopedic patient-matched guides. Following such recommendations may increase efficiency and consistency in review.

Dates

The announcement of the guidance is published in the Federal Register on May 7, 2026.

Supplementary Information

I. Background FDA is announcing the availability of a guidance for industry and FDA staff titled “Patient-Matched Guides for Orthopedic Implants.” FDA has developed this guidance document for members of industry who submit and FDA staff who review premarket submissions for patient-matched guides for orthopedic implants. 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. This guidance is intended to promote clarity and transparency as to expectations regarding submission recommendations for orthopedic patient-matched guides. Following such recommendations may increase efficiency and consistency in review. Additionally, this guidance provides recommended best practices regarding certain elements of the design process. This guidance was part of the 2015 initiative to incorporate stakeholder feedback during guidance development (80 FR 1424, January 9, 2015) available at https://www.federalregister.gov/documents/2015/01/09/2015-00115/medical-device-user-fee-and-modernization-act-notice-to-public-of-website-location-of-fiscal-year. Specific questions were posed to solicit input into the context of the guidance and comments were collected through Docket No. FDA-2012-N-1021. A notice of availability of the draft guidance appeared in the Federal Register of June 28, 2023 (88 FR 41967). FDA considered comments received and revised the guidance as appropriate in response to the comments, including clarification of recommendations that are technical in nature ( e.g., device description, cadaveric testing), as well as clarification of certain modifications that FDA would consider likely to require submission of a new 510(k) submission. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Patient-Matched Guides for Orthopedic Implants.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Electronic Access Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also available at https://www.regulations.gov or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to download an electronic copy of “Patient-Matched Guides for Orthopedic Implants” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI01400006 and complete title to identify the guidance you are requesting. III. Paperwork Reduction Act of 1995 While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in the following table have been approved by OMB: 21 CFR part Topic OMB Control No. 807, subpart E Premarket notification 0910-0120 820 Current Good Manufacturing Practice (CGMP); Quality Management Systems Regulation (QMSR) 0910-0073 812 Investigational Device Exemption 0910-0078 814, subparts A through E Premarket approval 0910-0231 800, 801, and 809 Medical Device Labeling Regulations 0910-0485 Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2026-09023 Filed 5-6-26; 8:45 am]