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The FDA Process for the Evaluation and Approval of Orthopaedic Devices

Dr. Kirkpatrick is Professor and Chair, Department of Orthopaedic Surgery, University of Florida College of Medicine, Jacksonville, FL. Mr. Stevens is Chief, Orthopaedic Spine Devices Branch, Division of General, Restorative, and Neurological Devices, Office of Device Evaluation, US Food and Drug Administration, Rockville, MD.

Dr. Kirkpatrick or a member of his immediate family serves as a consultant to or is an employee of the US Food and Drug Administration. Mr. Stevens is an employee of the US Food and Drug Administration.

Reprint requests: Dr. Kirkpatrick, Department of Orthopaedics and Rehabilitation, University of Florida College of Medicine, 655 West 8th Street, Jacksonville, FL 32209.

The US Food and Drug Administration (FDA) is a scientific, regulatory, and public health agency whose authority includes overseeing the marketing of products relevant to medical practice. Devices are classified based on the extent of oversight needed to ensure public safety. Divisions within the FDA provide specific expertise regarding drugs, devices, biologic products, and combinations thereof. Various pathways exist to apply for marketing through the FDA, depending on the nature of the product and its intended use. Expert panels advise the agency on issues related to product safety and efficacy, and clinical studies may be required to provide data based on these parameters. Clinical data are monitored postapproval for potential adverse events not evident in earlier trials. Orthopaedic surgeons are involved in all aspects of the FDA as employees, consultants, product advocates, participants in clinical trials and advisory panels, and experts involved in the appropriate reporting of adverse events.

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