Harvard Medical School, Boston, Massachusetts (K.T.K.).
Department of Otolaryngology - Head and Neck Surgery, The Ohio State University College of Medicine, Columbus, Ohio (V.K.R.).
Ann Intern Med. 2024 Nov;177(11):1558-1565. doi: 10.7326/ANNALS-24-00728. Epub 2024 Oct 8.
Nearly all medical devices reviewed by the U.S. Food and Drug Administration (FDA) are authorized via the 510(k) clearance process. Established in 1976, this review pathway bases authorizations on the comparability of new devices to previously authorized devices ("predicates"). This evaluation usually does not require clinical evidence of safety and effectiveness. Advocates of the 510(k) clearance process tout its support for device innovation and rapid market access, and critics of the 510(k) clearance process express that it may inadequately protect patient safety. In September 2023, the FDA issued 3 guidance documents that, if finalized, would significantly change medical device regulation. This article provides clinical and regulatory context for the proposed guidance documents, which focus on predicate selection, clinical testing requirements, and implantable devices, and identifies opportunities for further reforms that promote transparency and patient safety.
美国食品和药物管理局 (FDA) 审查的几乎所有医疗器械都是通过 510(k) 许可程序获得授权的。该审查途径于 1976 年建立，其授权依据是新设备与先前授权设备的可比性（“前序设备”）。这种评估通常不需要安全性和有效性的临床证据。510(k) 许可程序的支持者吹捧其对设备创新和快速市场准入的支持，而 510(k) 许可程序的批评者则表示，它可能不足以保护患者安全。2023 年 9 月，FDA 发布了 3 份指导文件，如果最终确定，将对医疗器械监管产生重大影响。本文为拟议的指导文件提供了临床和监管背景，重点关注前序设备选择、临床测试要求和植入式设备，并确定了进一步改革的机会，以提高透明度和患者安全。
