The QMN Weekly Bulletin
Quality / Medical Devices / Regulatory Affairs / Commercial Operations

FDA: Boom in Recalls Due to Greater Reporting, Focus on Quality, Safety

April 4, 2014
A new FDA report showing medical device recalls nearly doubled from fiscal year 2003 to 2013 should not sound any alarms, the agency says. Overall, the number of recalls jumped 97 percent during the decade. In 2003, the agency logged 604 recalls — seven Class I, 460 Class II and 137 Class III.
Devices & Diagnostics Letter