The perceived ambiguity of the US Food and Drug Administration’s (FDA) guidance on Unique Device Identifier (UDI) requirements for combination medical devices could lead to inconsistent implementation, a legal expert has said.
Released in June, the FDA’s revised guidance addresses how UDI requirements apply to combination products containing device constituent parts, including single-entity, co-packaged, and cross-labelled products that combine drugs, biologics, and/or devices. The draft guidance is the latest phase in the FDA’s UDI rule of 2013 that aims to standardise the submission of information to the Global Unique Device Identification Database (GUDID) for combination products.
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Since its publication, industry observers have noted that within the regulation, inconsistency exists between UDI regulations and the guidance with respect to exceptions.
Kyle Faget, partner at law firm Foley & Lardner highlighted that a key issue surrounding the latest draft guidance is that it creates the expectation that device constituent parts of a drug- or biologic-led co-packaged combination product should bear a UDI, while current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.
Speaking to Medical Device Network, Faget highlighted that under the guidance, the roles and responsibilities of the combination product firm and device constituent supplier seem to be unclear.
“Industry has called for clarification regarding the general traceability requirements and roles and responsibilities between pharma and device constituent suppliers. Lastly, the guidance assumes device constituent parts are 510(k) cleared/PMA approved products,” Faget said.
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By GlobalDataFaget goes on to say: “We recommend making clarifications 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.”
Other feedback from industry
Expressing similar concerns, the Medical Device Manufacturing Association (MDMA) has also requested that the 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.
In a docket response filed in September, the MDMA said: “For example, bottles are never sold as a standalone 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.”
Regarding the guidance’s apparent assumption that device constituent parts are 510(k) cleared or PMA approved products, the Advanced Medical Technology Association (AdvaMed) said: “For a 510(k) cleared, de novo-authorised, or PMA-approved device, it is correctly expected to have full UDI compliance from all layers, including primary package, and actual device (assuming reusable).
“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.”
Due to these control limitations, it should be permissible, consistent with the regulations, to not provide UDI information for the constituents, the trade association added.
