Yang Brian W, Iorio Matthew L, Day Charles S
1Harvard Medical School, Boston, Massachusetts 2Department of Orthopaedic Surgery and Division of Plastic Surgery, Beth Israel Deaconess Medical Center, Boston, Massachusetts 3Bone and Joint Center, St. Elizabeth's Medical Center, Brighton, Massachusetts.
J Bone Joint Surg Am. 2017 Mar 15;99(6):e26. doi: 10.2106/JBJS.16.00050.
The 2 main routes of medical device approval through the U.S. Food and Drug Administration are the premarket approval (PMA) process, which requires clinical trials, and the 510(k) premarket notification, which exempts devices from clinical trials if they are substantially equivalent to an existing device. Recently, there has been growing concern regarding the safety of devices approved through the 510(k) premarket notification. The PMA process decreases the potential for device recall; however, it is substantially more costly and time-consuming. Investors and medical device companies are only willing to invest in devices if they can expect to recoup their investment within a timeline of roughly 7 years. Our study utilizes financial modeling to assess the financial feasibility of approving various orthopaedic medical devices through the 510(k) and PMA processes. The expected time to recoup investment through the 510(k) process ranged from 0.585 years to 7.715 years, with an average time of 2.4 years; the expected time to recoup investment through the PMA route ranged from 2.9 years to 24.5 years, with an average time of 8.5 years. Six of the 13 orthopaedic device systems that we analyzed would require longer than our 7-year benchmark to recoup the investment costs of the PMA process. With the 510(k) premarket notification, only 1 device system would take longer than 7 years to recoup its investment costs. Although the 510(k) premarket notification has demonstrated safety concerns, broad requirements for PMA authorization may limit device innovation for less-prevalent orthopaedic conditions. As a result, new approval frameworks may be beneficial. Our report demonstrates how current regulatory policies can potentially influence orthopaedic device innovation.
医疗器械通过美国食品药品监督管理局批准的两条主要途径是上市前批准（PMA）程序，该程序需要进行临床试验；以及510(k)上市前通知程序，如果器械与现有器械实质等同，则可免除临床试验。最近，人们对通过510(k)上市前通知程序批准的器械安全性的担忧日益增加。PMA程序降低了器械召回的可能性；然而，其成本要高得多，耗时也长得多。投资者和医疗器械公司只有在预计能在大约7年的时间内收回投资的情况下，才愿意投资医疗器械。我们的研究利用财务模型评估通过510(k)和PMA程序批准各种骨科医疗器械的财务可行性。通过510(k)程序收回投资的预期时间为0.585年至7.715年，平均时间为2.4年；通过PMA途径收回投资的预期时间为2.9年至24.5年，平均时间为8.5年。我们分析的13种骨科器械系统中有6种需要超过我们的7年基准时间才能收回PMA程序的投资成本。采用510(k)上市前通知程序，只有1种器械系统收回投资成本的时间会超过7年。尽管510(k)上市前通知程序已显示出安全问题，但对PMA授权的广泛要求可能会限制针对不太常见的骨科疾病的器械创新。因此，新的批准框架可能会有益。我们的报告展示了当前监管政策如何可能影响骨科器械创新。
