ral Register Proposed rule: FDA is amending its 7/10 proposed rule (77 FR 40736) to establish a unique device identification (UDI) system the FD&C Act. It is changing some of the proposed effective dates for requirements applicable to implantable, life-supporting, and life-sustaining devices, so that the requirements applicable to these devices will be effective no later than two years from finalization of the rule. Under the 7/10 proposed rule, all Class 3 devices and all devices licensed under the Public Health Service Act would be required to bear a UDI within one year of the date FDA publishes a final rule; thus, this effective date does not need to be changed. The agency is now proposing to require all other implantable, life-supporting, and life-sustaining devices (i.e., those that are not already subject to the one-year effective date) to bear a UDI within two years following the publication of a final rule. To view this notice, click here.
