FDA draft guidance outlines UDI requirements for combination products
The US Food and Drug Administration (FDA) has released draft guidance outlining when combination products with device constituent parts are subject to unique device identifier (UDI) requirements.A combination product can include a single entity combination product with two or more drug/device/biological product components, a co-packaged combination product with two or more drug/device/biological products, a co-packaged combination product with two or more drug/device/biological products packaged separately but intended to be used together, or a cross-labeled combination product consisting of a drug/device/biological product that is packaged separately but intended to be used with another drug/device/biological product.
In general, FDA said a combination product with device constituent parts needs to follow UDI requirements, but the entire combination product may be exempt if each individual constituent part is not subject to UDI requirements. This echoes comments made by agency officials in other venues about how sponsors should treat UDI requirements in combination products that involve device constituent parts (RELATED: Combination products: FDA experts address UDI, harmonization, OPQ reorganization, Regulatory Focus 07 December 2023).
The agency noted that Class I devices that are exempt from good manufacturing practice (GMP) requirements under 21 CFR part 820, and investigational devices exempt under 21 CFR part 812 are examples of devices not subject to UDI requirements.
“If all device constituent parts of a combination product would otherwise be considered Class I devices if they were stand-alone devices intended for the same use in the combination product, then the combination product is considered not subject to production identifier requirements,” they wrote.
Another example of an exemption is a Class I device that has a universal product code (UPC), which meets UDI requirements by having the UPC on its label.
Single-entity combination products with a National Drug Code (NDC) and certain co-packaged combination products with an NDC are also exempt from UDI requirements, but the device component of a drug- or biologic-led combination product with an NDC is required to have a UDI on the device component. Device components of cross-labeled combination products are required to have a UDI because of how the constituent parts are distributed.
Examples of single-entity combination products that should contain a UDI include device-led products such as drug eluting stents or leads, antimicrobial coated sutures, bone cements with antibiotics, and condoms with spermicide. Single-entity combination products that should not have a UDI are drug- or biologic-led products such as prefilled drug or biologic delivery devices, solid oral dosage form drugs with sensors, and drug-coated contact lenses.
Combination products can have multiple identifiers, such as a UDI or NDC, on the label or package and “can be subject to multiple requirements related to product identification,” FDA explained. If the sponsor purchased device constituent parts from a supplier, it is generally the supplier’s responsibility to provide a UDI for that device product, FDA said.
For co-packaged combination products that involve multiple identifiers, device constituent parts already labeled with a UDI by a supplier do not need to be re-labeled, but device constituent parts placed in the package by the combination products firm need to be labeled, FDA said. For instance, if a firm wanted to package three device constituent parts (a syringe, a vial adapter, and needle) in with a vial of lyophilized powder and vial of diluent, and the needle was already pre-labeled and came with its own UDI, the firm would need to provide a UDI for the label on the syringe and a vial adapter but not the needle.
The agency recommended not placing a UDI on the label of a single-entity combination product and placing a UDI on a device-led co-packaged combination product, but not on each device constituent part within the container of the co-packaged product. For non-device-led co-packaged combination products, the device components should be labeled with a UDI.
When submitting a combination product to the Global Unique Device Identification Database (GUDID), sponsors need to create an account on the agency’s UDI website and provide their FDA premarket authorization number or active FDA listing number.
FDA encouraged sponsors with specific questions about their combination product to contact the Office of Combination Products or the FDA center that is reviewing their product.
Comments can be submitted via regulations.gov through 24 September 2025.
Draft guidance
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