UDI Enforcement May Stall: Address Unwritten Requirements, Experts Urge

FDA enforcement of unique device identifier (UDI) requirements will likely be delayed to allow for ample implementation time, but unwritten mandates in the draft rule with the potential to snarl inspections require prompt attention, compliance experts and former agency officials say. The finalized version of the UDI rule is expected to closely resemble the draft, which appears to contain a number of “implicit” changes to current regulations that investigators may pick up on, Dan O’Leary, president of Ombu Enterprises, said Sept. 21.
Devices & Diagnostics Letter