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FDA releases millions of adverse event reports on medical devices
Modern Healthcare

The U.S. Food and Drug Administration has released more than 20 years of reports detailing adverse events involving medical devices, ending a program that allowed some manufacturers to keep safety issues from the public.

The agency announced on Friday it has made publicly available approximately 6 million adverse event reports dating back to 1999 that were previously not included in the federal database Manufacturer and User Facility Device Experience, or MAUDE. Those reports previously were exempted under the FDA’s Alternative Summary Reporting program.