Devicemakers Told to Follow GHTF in Lieu of Delayed FDA UDI Rule

As the Center for Devices and Radiological Health has once again pushed back the release of its long-anticipated proposed unique device identifier (UDI) rule, devicemakers should look at the Global Harmonization Task Force’s (GHTF) new draft guidance on UDI so they can begin planning their internal systems.

The GHTF guidance is intended to establish a single UDI system to facilitate the traceability of devices worldwide. But the safety benefits will only be achieved if all stakeholders use the globally harmonized system without regional adaptations, GHTF says.

The guidance proposes a risk-based approach to implementing the global system and determining what level of packaging requires a UDI.
The GMP Letter