Apr 25, 2013

The US Food and Drug Administration has published a report updating its plans for a nationwide medical device post-market surveillance system, including implementation of a Unique Device Identification (UDI) framework.

The agency’s Center for Devices and Radiological Health (CDRH) plans five major steps in 2013 to establish the national post-market surveillance system:

  • Setting up a Medical Device Postmarket Surveillance System Planning Board to develop policies and procedures of the system
  • Implementing a nationwide UDI system, including a global UDI database
  • Advocate for national and international medical device registries to facilitate UDI worldwide
  • Modernize adverse event reporting via a new mobile application for voluntary reporting, and by launching a functional version of an FDA Adverse Event Reporting System
  • Implement new methods for evidence generation and evaluation

The FDA report coincides with the release of new UDI guidelines by the International Medical Device Regulators Forum (IMDRF), as well as European Commission recommendations for an EU-wide UDI system. As expected, both US and EU regulators have based their proposed systems largely on the IMDRF recommendations, boding well for a harmonized UDI system on a global—or at least international—scale.

Source: US Food and Drug Administration

Stewart Eisenhart


  • Stewart Eisenhart