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.
The International Medical Device Regulators Forum (IMDRF), formerly known as the Global Harmonization Task Force or GHTF, has published long-awaited draft recommendations for Unique Device Identification (UDI) systems (PDF) for medical devices.
Although some market regulators including European and US authorities are developing their own national UDI systems, these regulators’ plans hew closely to IMRF principles. The organization has kept its recommendations broad enough to allow some flexibility among national regulators to pursue their own UDI frameworks, as well. The IMDRF warns against developing national-level UDI systems that vary from one another, however, which would defeat the purpose of UDI altogether.
The IMDRF identifies three core components of a UDI system: using globally accepted standards to develop the system, applying UDI information on device labels, and submitting appropriate information to a UDI Database.
Among more specific recommendations issued by the IMDRF:
- A UDI should include both a Device Identifier (UDI-DI) and a Production Identifier (UDI-PI).
- Each component or accessory of a product that is regulated as a medical device must be assigned its own UDI.
- Manufacturers must assign new UDI-DIs to their devices whenever changes are made that could cause misidentification or less traceability of their products.
The draft recommendations also mention rules targeting implantable devices, reusable devices requiring sterilization, IVD kits and stand-alone medical device software systems.
Implications of UDI compliance for medical device manufacturers pursuing European CE Marking, US FDA 510(k) clearance or other market registrations will not be insignificant. European regulators have already published proposals for an EU-wide UDI system, and the US FDA should unveil its own proposed system in the near future. Although medical device manufacturers should expect some degree of variance between markets in terms of UDI compliance, they now have a good idea of broad device identification requirements they’ll need to meet once these systems are brought online.
Background: The harmonized UDI concept, first developed by the IMDRF’s predecessor organization GHTF (“Guidance on a Unique Device Identification System (UDI) for Medical Devices”), is intended to provide a unified, worldwide system to provide more efficient medical device identification and tracking capabilities across markets.
REFERENCE: US FDA website and Emergo Group (May 2013)