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Implantable Device Labeling Stepped Up

WASHINGTON (CN) - The Food and Drug Administration has amended its proposal to require unique device identifier (UDI) information on a variety of medical devices, to accelerate the implementation date for certain devices to be in compliance with recently enacted legislation, according to the agency's proposed rule amendment.

The July proposal included labeling requirements for UDIs on a range of medical devices to be reported to a proposed Global Unique Device Identification Database (GUDID), according to the amendment.

The original action proposed a phased implementation for the labeling and reporting requirements, with some going into effect immediately upon publication of the final rule, and others going into effect at intervals of one year, three years, five years and seven years after final publication, the amendment stated.

However, the recently enacted Food and Drug Administration Safety and Innovation Act contains requirements for manufacturers to submit the UDI information to the GUDID within two years of the finalization of the rule.

These new timeframe requirements have prompted the agency to amend the proposal's implementation dates for the only category of devices it considers to be affected by the new legislation, and to request comments as to whether other devices may also fit the category, the agency said.

The devices affected by the amendment are those subject to direct UDI marking on the device itself, which are also "implantable, life-saving, and life sustaining.'' The agency interprets "life-saving" to have the same meaning as "life-supporting" in the proposed rule and its amendment, according to the action.

Learn more by clicking on the document icon for this action and others.

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