CDRH Sees Steep Increase in MDR Reports, Warnings

Medical device reports (MDRs) have increased 65 percent last year, and warning letters citing MDR procedures are on the rise as well. The device division received more than 339,000 reports by the end of last year, compared with 205,000 in 2009. Approximately 90 percent of those reports were entered by devicemakers, Kathleen Cummings, an analyst in the evaluation branch in the Division of Post Market Surveillance at CDRH, said during a Food and Drug Law Institute webinar.
Devices & Diagnostics Letter