Kyle Faget on FDA UDI Guidance – 'Industry has called for clarification'

Foley & Lardner LLP partner Kyle Faget weighed in on the U.S. Food and Drug Administration’s guidance on Unique Device Identifier (UDI) requirements for combination medical devices in the Medical Device Network article, “FDA’s UDI guidance ‘ambiguity’ could lead to inconsistent implementation.”

The FDA’s guidance, released in June 2025, governs how UDI rules apply to products that contain combinations of devices, drugs, and biologics.

Faget noted the FDA’s draft guidance creates the expectation that device constituent parts of a drug- or biologic-led co-packaged combination product should bear a UDI, while current regulation allows for an exception to this requirement.

“Industry has called for clarification regarding the general traceability requirements and roles and responsibilities between pharma and device constituent suppliers,” Faget explained. “Lastly, the guidance assumes device constituent parts are 510(k) cleared/PMA approved products.”

Faget added that she recommends making clarifications as appropriate “to reduce regulatory ambiguity and the risk of different interpretations or errors and inconsistent industry execution.”

“The inconsistency and perceived ambiguity may lead to different interpretations/errors and inconsistent industry implementation,” she added.

Faget’s commentary also appeared in Yahoo! News.