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December 15, 2021

Deadly Legacy—The 510(k) Path to Medical Device Clearance

Author Affiliations
  • 1Brown University, Providence, Rhode Island
  • 2Program in Women’s Oncology, Brown University, Providence, Rhode Island
  • 3Harvard Law School, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University, Cambridge, Massachusetts
JAMA Surg. 2022;157(3):185-186. doi:10.1001/jamasurg.2021.5558

On December 29, 2020, the US Food and Drug Administration (FDA) issued final guidance to the effect that laparoscopic power morcellators (LPMs) should be used “only with a tissue containment system” when performing a myomectomy or a hysterectomy.1 The FDA further decreed that LPMs are not to be used “in patients who are post-menopausal or over 50 years of age, or candidates for en bloc tissue removal through the vagina or via a mini-laparotomy incision.”1 In so doing, the FDA sought to obviate the inadvertent intraperitoneal dissemination of occult sarcomatous uterine tumors and the dire consequences thereof.2 Only short shrift, however, was given to the root causes of the attendant 30-year saga defined by a forgiving 510(k) regulatory path and passive surveillance of its aftermath.2 Herein we assess the rigor applied by the FDA to the premarket clearance and postmarket surveillance of medical devices and consider potential remedies to the inherent shortcomings thereof.

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