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

2017; American Medical Association; Volume: 318; Issue: 4 Linguagem: Inglês

10.1001/jama.2017.7704

1538-3598

Rita F. Redberg, Alison Jacoby, Joshua M. Sharfstein,

Healthcare cost, quality, practices

This Viewpoint uses the example of power morcellator devices to discuss the wider scope of US Food and Drug Administration regulations and postmarketing surveillance necessary to ensure patient safety.