CDRH Misses Target Again for Releasing UDI Rule, Looks to GHTF Draft Guidance

CDRH has once again pushed back the release of its long-anticipated proposed unique device identifier (UDI) rule, which had been set to come out this year. The rule has been drafted but is going through the review process, Jay Crowley, senior adviser for patient safety at CDRH, said. He hopes the proposed rule will be published in the first quarter of next year, once agency questions have been answered about implementation and the meaning of certain provisions. In the meantime, Crowley said devicemakers should look at the Global Harmonization Task Force’s (GHTF) new draft guidance on UDI so they can begin planning their internal systems.
Devices & Diagnostics Letter