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July 25, 2017

Power Morcellators, Postmarketing Surveillance, and the US Food and Drug Administration

Author Affiliations
  • 1Department of Medicine, Division of Cardiology, University of California, San Francisco
  • 2Editor of JAMA Internal Medicine
  • 3Department of Obstretrics and Gynecology, University of California, San Francisco
  • 4Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
JAMA. 2017;318(4):325-326. doi:10.1001/jama.2017.7704

Many changes are coming to the US Food and Drug Administration (FDA) by virtue of the passage of the 21st Century Cures Act, the recent confirmation of a new commissioner, and the current administration in Washington, DC, that is inclined toward reducing regulation, a key function of this agency. The clinical community depends on high-quality evidence about medical products, and regulatory oversight is a key mechanism for ensuring collection of that evidence. This point becomes especially apparent when important data to guide care are lacking, as illustrated by the recent example of power morcellators.