FDA To Expand Postmarket Surveillance Of Medical Devices, Per GAO Report Requested By Lawmakers

A government report requested by US lawmakers Debbie Dingell and Anna Eshoo to review the FDA’s postmarket surveillance of medical devices stresses that strengthening the system is critical to addressing adverse events linked to devices after they hit the market.

ADVERSE EVENTS
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In 2022, representatives Debbie Dingell, D-MI, and Anna Eshoo, D-CA, requested that the Government Accountability Office review the US Food and Drug Administration’s postmarket surveillance of medical devices and provide recommendations on how the agency can better identify adverse events and increase device safety.

Dingell and Eshoo said they made the request to better understand and improve existing systems for medical device surveillance and...

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