New FDA rule requires electronic reporting of adverse events

FDA has issued a final rule requiring medical device manufacturers to electronically submit reports of adverse events associated with their products.

A 2009 proposed rule called for medical device companies to electronically report injuries or deaths associated with their products on a voluntary basis. These reports are currently submitted on paper.

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

The new rule requires 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 says manufacturers will save an estimated $9.2 million annually in administrative costs.