The FDA Has a Vast Hidden Repository of Reports on Device-Related Injuries and Malfunctions.
Device makers would be able to seek a special “exemption” to avoid reporting certain complications to the public database. The manufacturers would instead send the FDA a spreadsheet of injury or malfunctions each quarter, half-year or year.
From 2014 through 2017, the overall number of alternative summary reports filed by device makers rose from 431,000 to 481,000.
Several doctors and officials, including former FDA deputy commissioner and commissioner from 2015 to 2017, said in an interview that he was unaware of the program.
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