FDA To End Nonpublic Medical Device Adverse Event Reporting Program

Mealey's (May 8, 2019, 8:30 AM EDT) -- SILVER SPRING, Md. — The Food and Drug Administration on May 2 said it is ending its 22-year-old alternative summary reporting program for all medical devices, a program that allowed medical device manufacturers to submit summary reports of adverse events that were not publicly available on the agency’s Manufacturer and User Facility Device Experience (MAUDE) database....

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