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FDA Quietly Sunsetting Summary Reporting Program For Adverse Events, Readies Public Release Of Millions Of Pre-2017 Summarized MDR Reports

 
• By Shawn M. Schmitt

The US FDA expects to turn the lights out on its 22-year-old Alternative Summary Reporting Program for adverse events at the end of May, the agency tells Medtech Insight. But it's the FDA's upcoming online release of millions of summarized Medical Device Reports sent to the agency between 1998 and 2017 that could have the tongues of industry – and the public – wagging.

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When the US Food and Drug Administration announced it was shutting down its Alternative Summary Reporting Program for adverse events, it did so with little fanfare.

The agency quietly made the announcement on its Medical Device Reporting webpage on 2 May. On that same day, news of the program's imminent demise was buried in paragraphs nine and 10 of a rather lengthy joint press statement on breast implant safety by FDA Principal Deputy Commissioner Amy Abernathy and Center for Devices and Radiological Health Director Jeff Shuren

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