Adverse Event Reports Hit All-Time High; FDA Warns Firms About MDRs,Complaint Handling

摘要

Athough nearly 1 million adverse events were reported to FDA via its Medi cal Device Reporting system last year, the agency is consistently warning manufacturers for failing to have adequate MDR procedures in place. A record 939,233 MDRs were submitted to FDA in calendar year 2012, according to statistics provided to "The Silver Sheet" by CDRH's Office of Surveillance and Biometrics (OSB).