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As Industry Debates Postmarket Issues, FDA Says Firms Underreport MDRs

This article was originally published in The Silver Sheet

Executive Summary

POSTMARKET SURVEILLANCE RECOMMENDATIONS contained in an April report from the Heart Rhythm Society could eventually have a far-reaching effect on all manufacturers, according to Kimber Richter, deputy director for medical affairs in CDRH’s Office of Compliance. "We’re very interested in seeing what works," she said. Meanwhile, FDA officials say firms often underreport adverse events and make errors when completing medical device reports. Companies "need to do the most thorough job possible in documenting on the [3500A] form what exactly happened, with as much information as they can provide to us," says Susan Gardner, director of CDRH’s Office of Surveillance and Biometrics. However, a health care attorney says the agency could make the system more efficient by limiting malfunction reporting to high-risk devices...

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