FDA’s Center for Devices and Radiological Health (CDRH) has finally picked a new adverse event (AE) reporting tool for devices. It’s slated to be in place by the end of the year. Of course, the agency missed a few deadlines to pick a new tool, so that deadline could slip, too.
The creaky MAUDE, or Manufacturer and User Facility Device Experiences system, is out. It’ll be replaced by a PRIMO internet-based software platform developed by the November Research Group (NRG). FDA just inked a five-year contract with NRG.
While NRG touts its tool as a cut-above commercially available pharmacovigilance solutions primarily focused on generating the reports then sent to regulators, PRIMO is specifically designed for streamlined report intake and high-volume, intelligent report review, according to the company.
NRG’s tool is designed to, among other things, speed AE reporting into CDRH, and generate more accurate follow-up data returning to the device maker from the agency.
Years in the making, the upgrade was part of a concerted CDRH that included the September 2012 release of a white paper, “Strengthening Our National System for Medical Device Postmarket Surveillance.” The white paper laid out the market conditions demanding an AE reporting system upgrade. It also included four specific calls to action:
- Establish a Unique Device Identification System and Promote Its Incorporation into Electronic Health Information;
- Promote the Development of National and International Device Registries for Selected Products;
- Modernize Adverse Event Reporting and Analysis; and,
- Develop and Use New Methods for Evidence Generation, Synthesis and Appraisal.
CDRH has said in the past that it receives more than a thousand AE’s each day.