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Comment & Response
Health Care Policy and Law
February 21, 2022

Reporting Device-Associated Death Events to the FDA

Author Affiliations
  • 1Office of Product Evaluation and Quality, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland
JAMA Intern Med. 2022;182(4):462. doi:10.1001/jamainternmed.2021.8509

To the Editor We write to respond to a recent report by Dr Lalani and colleagues1 regarding device-associated adverse events reported to the US Food and Drug Administration (FDA). Adverse event reports submitted to the MAUDE (Manufacturer and User Facility Device Experience) database2 are an important tool in the postmarket surveillance of medical devices. The FDA provides public access to these data to promote transparency and the opportunity for research and analyses. We write to address the following points.

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