Ross Joseph S, Blount Katrina L, Ritchie Jessica D, Hodshon Beth, Krumholz Harlan M
Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA.
Med Devices (Auckl). 2015 May 27;8:241-9. doi: 10.2147/MDER.S82964. eCollection 2015.
In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway.
We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions.
Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.
在美国，一旦医疗设备可供使用，美国食品药品监督管理局（FDA）已制定了多项要求，以确保对设备安全性和有效性进行持续的上市后监测。我们的目标是确定医疗设备制造商启动上市后临床研究或加强FDA对通过FDA上市前批准（PMA）途径最常获批的高风险设备的上市后监测要求的频率。
我们对在加利福尼亚州、明尼苏达州和马萨诸塞州开展业务且销售通过PMA途径获批设备的47家制造商进行了横断面调查。在22名受访者中（回复率 = 47%），几乎所有人都自我报告开展了上市后临床研究，通常为1至5项；只有1名受访者报告从未开展过上市后临床研究。虽然制造商开展这些研究大多是为了满足FDA的要求，但也报告了其他原因，包括性能监测与监督以及市场接受度举措。通过对问题的开放式回答描述了开展和不开展上市后临床研究的风险。
医疗设备制造商通常应FDA要求启动上市后临床研究。这些研究的临床数据应纳入国家上市后监测举措。
