CDRH Will Develop New MDR Database Rather Than Transitioning to AERS

CDRH has canceled its plan to move medical device reports (MDRs) to the FDA’s adverse event reporting system (AERS) by year’s end in a move that could delay the mandatory electronic submission of MDRs. Instead, the center is developing a new database to replace the out-of-date Manufacturer and User Facility Device Experience (MAUDE), Susan Gardner, director of CDRH’s Office of Surveillance and Biometrics, said. The FDA had promised to transition devicemakers to AERS by the end of 2010 in response to a report from HHS’ Office of Inspector General that was critical of MAUDE and CDRH’s inability to use MDRs in a systematic manner to address safety concerns.
Devices & Diagnostics Letter