Orthopaedic joint devices: the FDA's short answers to your questions.

Abstract

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.