Patient-Matched Guides for Orthopedic Implants; Guidance for Industry and Food and Drug Administration Staff; Availability

Streszczenie

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.