FDA Requires Electronic Reports on Medical Device Issues

February 14, 2014 in News

On Thursday, FDA issued a final rule requiring medical device manufacturers to electronically submit reports of adverse events associated with their products, Modern Healthcare reports.


In 2009, FDA issued a proposed rule that called for medical device companies to electronically report injuries or deaths associated with their products on a voluntary basis. Currently, such companies send paper reports.

FDA estimates it receives about 200,000 adverse event reports annually from more than 20,000 medical device makers and importers. According to Modern Healthcare, it can take three to six days to analyze each paper report.

Details of Final Rule

The rule will require medical device manufacturers beginning Aug. 14, 2015, to electronically report adverse events.

User facilities — such as hospitals — are exempt from the e-reporting mandate.

FDA estimates that the medical device industry will face $40 million in one-time staff training and IT infrastructure costs to comply with the rule.

However, the agency said manufacturers will save about $9.2 million annually in administrative costs (Dickson, Modern Healthcare, 2/13).

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