FDA Could Act Faster on AEs Under New Reporting System
The FDA has chosen a long-awaited replacement for its outdated device adverse event reporting system — the Manufacturer and User Facility Device Experiences system, or MAUDE.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.
While devicemakers likely won’t see a big difference, “they’re going to see faster input and more accurate follow-up information coming from the center,” NRG President Seth Warhaftig said. The center will be able to respond faster as it reviews data more efficiently and aggregates it more effectively, he added.
This “should allow for the center to be able to react faster and be able to see things that they weren’t otherwise able to see in those downstream systems while using the current MAUDE system.”
PRIMO is specifically designed to receive, review and triage adverse event reports and can handle a high volume of reports from different electronic sources, NRG said, noting CDRH receives more than 1,000 reports each day. The system also has “an ‘intelligent’ report review function” and correspondence tracking features that should help regulators with decisionmaking and case management, NRG added.
CDRH has been hoping to replace the MAUDE system for some time. In 2011, the center said a replacement was coming by the end of that year, following a 2009 government report critical of MAUDE and of CDRH’s inability to use MDRs to address safety concerns.
Then, last September, the FDA released a white paper called “Strengthening Our National System for Medical Device Postmarket Surveillance” and said it would begin rolling out an enhanced postmarket surveillance program for medical devices by year’s end.
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