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Orthopaedic Joint Devices: The FDA’s Short Answers to Your Questions

Dr. Foy is Chief, Orthopaedic Joint Devices Branch, Division of General, Restorative and Neurological Devices, Center for Devices and Radiological Health, US Food and Drug Administration, Rockville, MD. Dr. Buch is a Deputy Director of the Division of General, Restorative and Neurological Devices, Center for Devices and Radiological Health, US Food and Drug Administration.

None of the following authors or a member of their immediate families has received anything of value from or owns stock in a commercial company or institution related directly or indirectly to the subject of this article: Dr. Foy and Dr. Buch.

No official support or endorsement of this article by the US Food and Drug Administration (FDA) is intended or should be inferred. The views presented in this article do not necessarily reflect those of the FDA. The findings and conclusions in this article should not be construed to represent any FDA determination, guidance, or policy.

This article briefly describes the US Food and Drug Administration regulatory process for medical devices, focusing on orthopaedic joint device examples. The mission of the Center for Devices and Radiological Health is to promote and protect the health of the public by ensuring that the medical devices that reach US consumers are safe and effective for their intended function. A question and answer section is included as a reference guide for the orthopaedic community to broadly address some common issues related to orthopaedic device constructs, such as hybridization of joint systems, labeling claims, modifications to ultra-high–molecular-weight polyethylene sought by manufacturers to minimize wear and osteolysis, combination products, and the responsibilities of an orthopaedic surgeon. The FDA relies on accurate scientific evidence and regulatory science to determine the safety and effectiveness of orthopaedic joint devices.