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Aug 30, 2016

UDI: When the Rule is Not Enough


FDA recently issued a draft guidance 
on the form and content of the UDI.

by Jennifer D. Newberger

Hyman, Phelps & McNamara, P.C


With less than two months to go before the UDI compliance date for Class II devices, on July 26, 2016, FDA issued a draft guidance related to what would seem to be the most basic of concepts: the form and content of the UDI. More specifically, the draft guidance states that its intent is to “clarify” for industry and FDA-accredited issuing agencies the form and content of the UDI, and to “better ensure the UDIs developed under systems for the issuance of UDIs are in compliance with” the UDI rule.



The UDI rule was finalized in September 2013, and FDA accredited the first issuing agency soon thereafter. Since then, the issuing agencies have been working with labelers to issue UDIs for Class III and Class II devices. Though FDA does not state in the draft guidance that it is aware of the issuance of any non-compliant UDIs, that seems to be the implication of the draft guidance. For example, the draft guidance states: “It is critical that each FDA-accredited issuing agency develop and operate a system for the assignment of UDIs that allow labelers to confidently use the FDA-accredited issuing agency’s system to develop UDIs that are compliance with the UDI labeling requirements . . . . Therefore, the FDA-accredited issuing agencies’ systems for issuing UDIs should align with the UDI labeling requirements.”


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For a labeler that has already obtained a UDI from an accredited issuing agency, this language in the draft guidance may cause some concern, as it seems to imply that the issuing agencies have in fact been issuing UDIs that are not in compliance with the UDI labeling requirements. Yet the draft guidance does not advise labelers to confirm compliance of the issued UDIs, nor does it explicitly state that FDA is aware the issuance of non-compliant UDIs. If FDA is aware of the such UDIs, it should so state, and should provide more direct guidance to labelers and issuing agencies about steps to take the remedy the non-compliance.

The draft guidance also introduces new concepts not discussed in the rule or in guidance issued by FDA since the rule was finalized. It is not clear if these concepts, such as “data delimiter” and “UDI carrier,” were already being used by the issuing agencies, or if they are entirely new ways of developing the form and content of a UDI. It may also be that these concepts are now being introduced as a means of remedying whatever concerns FDA may have about compliance of the UDIs that have been issued. The draft guidance simply does not say.

FDA should more explicitly discuss why the guidance was issued at this late stage, concerns about potential non-compliant UDIs, and why new terms are being introduced now. If labelers obtained non-compliant UDIs from issuing agencies, FDA should allow a grace period to come into compliance, and should not take enforcement actions against labelers that acted in good faith in obtaining a UDI.

Reprinted with permission from FDA Law Blog.


Jennifer D. Newberger helps medical device clients develop regulatory strategies, prepare product applications, comply with labeling, advertising, and promotion, and address enforcement actions. Ms. Newberger also works on combination product issues, and has expertise in FDA's regulation of human tissue-based products. She provides counsel on FDA aspects of regulatory due diligence, contracts, and transactions, and represents medical device companies before FDA. 

As part of her regulatory work, Ms. Newberger prepares IDE, 510(k), de novo, and PMA submissions or filings. In the area of compliance, she advises clients on MDRs, recalls, and QSRs. She has worked with companies ranging from start-ups to small and large manufacturers. 

Before joining the firm, Ms. Newberger was a policy advisor at FDA's Center for Devices and Radiological Health. Her knowledge of the government's internal processes and priorities guides her interpretation of emerging medical device regulation. Earlier in her career, Ms. Newberger was an associate in the health care group of a national firm. 

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