US FDA's device surveillance process comes under fire in BMJ investigation - update
This article was originally published in RAJ Devices
Executive Summary
The effectiveness of the US Food and Drug Administration's post-approval surveillance of medical devices has been questioned by an investigation published online in the BMJ1. The authors of the article were particularly critical of the agency's Manufacturer and User Facility Device Experience (MAUDE) database, which monitors adverse events linked with approved devices.
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