Adverse Event Reports Hit All-Time High; FDA Warns Firms About MDRs, Complaint Handling
• By Shawn M. Schmitt
As FDA sifts through almost a million Medical Device Reports submitted by manufacturers last year, the agency is trying to determine why so many adverse events are being reported. Isaac Chang, a director in CDRH’s Office of Surveillance and Biometrics, speculates that there could be a number of reasons for the large influx of MDRs, including high-profile recalls and a sharper FDA focus on human factors issues. Further, more than half of adverse events were reported to the agency on individual MedWatch forms in 2012 – a sharp increase over previous years. However, despite the extraordinary rise in reports, some firms continue to have trouble developing MDR procedures. Industry experts also weigh in on social media’s impact on adverse event reporting, and tips are shared for ensuring that complaints are properly handled by manufacturers.
Although nearly 1 million adverse events were reported to FDA via its Medical Device Reporting system last year, the agency is consistently warning manufacturers for failing to have adequate MDR procedures in place.
A record 939,233 MDRs were submitted to FDA in calendar year 2012, according to statistics provided to “The Silver Sheet” by CDRH’s
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