FDA Ends Secret Device Safety Database, Turns To Real-World Data

By David Roza / June 21, 2019 at 6:52 PM
FDA on Friday (June 21) formally scrapped its hidden database of safety incidents associated with certain medical devices and said it will beef up its public reporting program instead. At issue is a recently publicized alternative summary reporting (ASR) program that allowed certain medical device manufacturers to report device safety incidents on a quarterly basis without making those reports public. All of the ASR data submitted to the agency between 1999 and 2019 has now been posted on FDA’s website,...

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