FDA Moves Up Proposed UDI Deadline for Implantable, Life-Sustaining Devices
The Food and Drug Administration amended its July 10 proposed rule establishing a unique device identification system by moving up the effective date for devices that are “implantable, life-supporting, and live sustaining” to no later than two years from the finalization of the rule. The changes are pursuant to the Food and Drug Administration and Innovation Act (FDASIA), signed into law on July 9, which amended the Federal Food, Drug and Cosmetic Act (FD&C Act) in ways that require modification of the implementation timeline, FDA said.
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FDASIA also required FDA to issue proposed regulations establishing the unique device identification system by Dec. 31, and said FDA must finalize the proposed regulations no later than six months after the end of the comment period for the proposed rule.
Class III implantable, life-supporting, and life-sustaining devices, and implantable, life-supporting, and life-sustaining devices licensed under the PHS Act would not be affected by the proposed amendments, because unique device identifiers (UDI) would be required one year after finalization under the proposed rule. Class II, Class I, and unclassified implantable, life-supporting, and life-sustaining devices will be required to bear a UDI and submit data to the Global Unique Device Identification Database (GUDID) from one to five years earlier than previously proposed. The FDA is requesting comments by Dec. 19 on only these changes to the proposed rule. The period for general comments on the proposed rule closed on Nov. 7.
(See the FDA notice for a revised table of proposed effective dates. See also ITT's Online Archives 12070604 for summary of FDA's proposed rule to require unique device identifiers.)