FDA Requires Electronic Reports on Medical Device Issues
February 14, 2014 in News
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).