Stakeholders: FDA combo products UDI guidance is inconsistent with regulation

Several stakeholders have raised concerns that parts of the US Food and Drug Administration’s (FDA) draft guidance on unique device identifier (UDI) requirements for combination products are inconsistent with UDI regulations. They also raised concerns that several aspects of the guidance are ambiguous and would create confusion for manufacturers.

In June, FDA published a draft guidance outlining when combination products with device constituent parts are subject to UDI requirements and when the agency will allow exceptions. In response, several stakeholders wrote to the agency and argued its recommendations specifically for devices with constituent parts as part of a drug- or biologic-led combination product are inconsistent with current regulations. The medtech lobby groups AdvaMed and the Medical Device Manufacturers Association (MDMA) wrote to FDA to voice their concerns. (RELATED: FDA draft guidance outlines UDI requirements for combination products, Regulatory Focus 27 June 2025)

"The draft guidance appears to establish an expectation that device constituent parts of drug- or biologic-led co-packaged combination products should bear a UDI," said AdvaMed, citing a regulation that it argued allows exceptions.

"We propose adding language throughout the draft guidance to reflect the exception, consistent with the regulations," the group added.

Similarly, MDMA also raised concerns about what UDI exceptions are allowed under regulation. The group asked the agency to clarify UDI exceptions for device constituent parts and direct part marking (DPM).

Furthermore, MDMA expressed concern about how the FDA presented the roles and responsibilities of the combination product firms and device constituent suppliers in the guidance. The group asked the agency to clarify the general traceability requirements and the roles and responsibilities between drugmakers and device constituent suppliers.

"We also request FDA provide clarity on device constituent parts for OTC/monograph ophthalmic products/Genus devices (consumer health) and if these device constituent parts are exempt from UDI requirements," said MDMA. "For example, bottles are never sold as a stand-alone device and are 'unclassified' devices.

"Further, if genus products, specifically OTC/monograph drugs – drug-led DSCSA exempt, are not exempted from combination device UDI requirements, then we request additional clarity that if the NDC is printed on the carton and the GTIN is encoded in a UPC barcode, then the UDI requirements are considered met," the group added.

The Combination Products Coalition (CPC) raised similar concerns about FDA's decision to allow exemptions in the draft guidance when device constituent parts inside drug- or biologic-led co-packaged combination product kits do not carry a full UDI on their own labels but do include a National Drug Code (NDC) or Serialized Numerical Identifier (SNI). The group asked the agency to exercise enforcement discretion in such situations.

"In fact, one of the most common scenarios of concern to drug manufacturers is when they use a legally marketed (Class II) device constituent that does not carry the full UDI on the individual level due to the ‘bulk pack’ exception per 21 CFR 801.30(a)(3)," said CPC. “This most often occurs when individual needles—typically sold in bulk packages for use in clinics or pharmacies—are included at an individual level within a co-packaged kit.

"The individual needles’ very limited labeling area necessitates use of an exception," the group added.

MDMA said it was concerned that the guidance assumes device constituent parts are 510(k) cleared or have premarket approval. The group wants the FDA to clarify the regulatory ambiguity and added that such ambiguity could lead to the risk of different interpretations or errors and inconsistent industry practices.

"With reference to co-packaged and/or cross labeled drug-led combination products, the draft guidance appears to focus primarily on products with 510(k)-cleared/ PMA approved device constituents," said MDMA. "However, many real-world products may include device components that are not independently 510(k) cleared/PMA approved and are part of ANDA/NDA/BLA/351(k) submissions."

AdvaMed also raised concerns that the guidance assumes device constituent parts are FDA-authorized. The group said such an assumption would create specific challenges for industry.

"For a 510(k) cleared, de novo-authorized, or PMA-approved device, it is correctly expected to have full UDI compliance from all layers, including primary package, and actual device (assuming reusable)," said AdvaMed. "However, for device constituents approved pursuant to NDA/BLA (Biologics License Application/New Drug Application), for the device constituent supplier, there are implementation challenges because GUDID requires information that a device constituent supplier would not necessarily have control over.

"Because of these control limitations, it should be permissible, consistent with the regulations, to not provide UDI information for the constituents," the group added.

The Consumer Healthcare Products Association (CHPA) also wrote to FDA that the draft guidance could apply to consumer healthcare products despite the agency publishing a July 2022 UDI guidance that states that such class I products are exempt from Global Unique Device Identification Database (GUDID) submission requirements. The group noted that the agency's rationale was that asking companies to enter UDI data into the GUDID system could be too burdensome considering how frequently changes are made to the universal product codes (UPC) that are used as UDI.

"The rationale that led FDA to issue the UDI Policy should likewise apply to device constituents of combination products which meet the definition of a consumer health product," said CHPA "That is, if a device constituent of a combination product falls within the definition of consumer health product in the UDI Policy, it should likewise be exempt from GUDID submission requirements.

"However, it is not clear, based on the Draft Guidance, whether the Agency has taken the UDI Policy into account and if so, why it is not referenced in the Draft Guidance," the group added.

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Stakeholders: FDA combo products UDI guidance is inconsistent with regulation

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