There has been a lot of discussion surrounding the pending Unique Device Identification (UDI) regulation sreleased in July from the FDA and the desire to have them finalized. Once finalized, it will be welcome news for the industry.
A UDI is a unique number pertaining to a medical device that provides identification for different types of devices and access to useful and relevant information stored in a UDI database. The FDA’s draft UDI recommendations also mention rules targeting implantable devices, reusable devices requiring sterilization, IVD kits and stand-alone medical device software systems.
Due to the UDI’s specificity, it can make traceability of devices more efficient, allow easier recall of devices, fight against counterfeiting and improve patient safety. Standardizing the way medical devices are identified can also improve post-market surveillance and adverse event reporting and, ultimately, improve patient outcomes by making devices safer.
FDA and other healthcare systems plan to use the UDI for post-market surveillance and to generate information that can help guide your future product development.
The International Medical Device Regulators Forum (IMDRF), formerly known as the Global Harmonization Task Force or GHTF, published their long-awaited draft recommendations for UDI systems for medical devices in April. 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.
The regulatory focus in the global piece represents two issues:
- The first is the reality of the medical device space, where—unlike pharmaceuticals, which are often manufactured and labeled for a particular market—a medical device can be distributed in many, if not all regions of the world. The notion of a global UDI supports those types of global activities so we don’t need to have device manufacturers re-label products for different markets just to meet various identification needs.
- The second is the reality of the economy today, which is the sort of global nature of trade. A globally harmonized approach to UDI would support traceability, which is going to become a lot more important in the coming years.
Overall, several countries and regions, including the US and the EU, have been looking to implement a UDI proposal. In a separate statement to Regulatory Focus in early April 2013, FDA’s Jay Crowley, senior adviser for patient safety at CDRH, noted that all countries involved in the UDI process are “well aligned.” The FDA continues to work in the IMDRF working group on UDI, which includes good representation from US, EC, China, Japan and others.
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 a 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.