Foy Jonette R, Buch Barbara D
Orthopaedic Joint Devices Branch, Division of General, Restorative and Neurological Devices, Center for Devices and Radiological Health, US Food and Drug Administration, Rockville, MD, USA.
J Am Acad Orthop Surg. 2008;16 Suppl 1:S123-8. doi: 10.5435/00124635-200800001-00024.
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.
本文简要介绍了美国食品药品监督管理局对医疗器械的监管流程，重点以骨科关节器械为例。器械与放射健康中心的使命是，通过确保进入美国消费者手中的医疗器械在其预期功能方面安全有效，来促进和保护公众健康。文中包含一个问答板块，作为骨科界的参考指南，以广泛探讨一些与骨科器械结构相关的常见问题，如关节系统的混合、标签声明、制造商为尽量减少磨损和骨溶解而对超高分子量聚乙烯进行的改性、组合产品以及骨科外科医生的职责。美国食品药品监督管理局依靠准确的科学证据和监管科学来确定骨科关节器械的安全性和有效性。
