FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: PATIENT-MATCHED GUIDES FOR ORTHOPEDIC IMPLANTS; GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF; AVAILABILITY

WASHINGTON, May 7 -- Food and Drug Administration has issued a notice called: Patient-Matched Guides for Orthopedic Implants; Guidance for Industry and Food and Drug Administration Staff; Availability.

The notice was published in the Federal Register on May 7 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

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 manufactu...