FDAnews
www.fdanews.com/articles/158866-fda-could-act-faster-on-aes-under-new-reporting-system

FDA Could Act Faster on AEs Under New Reporting System

September 24, 2013
The FDA has chosen a long-awaited replacement for its outdated device adverse event reporting system — the Manufacturer and User Facility Device Experiences system, or MAUDE. By the end of this year, CDRH will replace MAUDE with the PRIMO web-based software platform from November Research Group (NRG), the company said. The FDA has a five-year contract for the system.
Devices & Diagnostics Letter