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Sep 24

FDA Finalizes Rule Requiring Unique Device Identification for Medical Devices

On September 20, 2013, the U.S. Food and Drug Administration (FDA) published a final rule that establishes the Unique Device Identification (UDI) system, finalizing the proposal first announced in July 2012. Our previous report of the proposed rule may be accessed here. In particular, the final rule will require that most medical devices distributed in the United States, with certain exceptions, bear a unique device identification on device labeling. It is also applicable to certain combination products that contain devices and to devices licensed under the Public Health Service Act. You can read the announcement here.

Section 519(f) of the Food, Drug, and Cosmetic Act (FDCA), provided for by the FDA Amendments Act of 2007 and the FDA Safety and Innovation Act of 2012, directs FDA to promulgate regulations establishing a unique device identification system for medical devices. Under the new UDI system, device manufacturers will be required to assign a unique identifier to the version or model of a device. This identifier, which must appear on the label and packaging of the device in “plain-text” form, will include a numeric or alphanumeric code and product-specific information such as the batch number and expiration date.

Additionally, the final rule requires that device labelers submit descriptive information about each version or model of a device with a UDI to the Global Unique Device Identification Database (GUDID) as part of the UDI system. Similar to the system in place for drugs, GUDID will be a publicly searchable database administered by the FDA and it will contain key descriptive information about every medical device with an identifier. The FDA has published draft guidance for industry outlining the process for submitting information to the GUDID.

In sum, medical devices must be in compliance with the rule’s provisions by the dates listed in the text, which calls for staggered implementation for unique device identification. One year after publication, for example, labels and packages of Class III medical devices and devices licensed under the Public Health Services Act must bear a UDI. The final rule also identifies general exceptions from the requirement for a label of a device to bear a UDI and describes the process for other labelers to request an exception or alternative placement of the UDI. Many low risk (Category I) devices are exempt from some or all of the rule’s requirements.

If you have any questions about the UDI system or any medical device regulations, please contact us at: contact@giannamore-law.com.

FDA Attorney

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