Combination Products continue to be at the forefront of regulatory chatter. Our customers, both medical device and pharmaceutical, are regularly coming to us with questions surrounding this topic. How do I decide if my product is a combination product? What are the regulations for a combination product? What submissions do I need to make for a regulatory product? The answers are rarely straightforward because combination products are not straightforward, but we have done our best to break this nuanced topic down. Please continue reading to learn more about combination products and reach out to us with any additional questions: [email protected] or [email protected].
What is a combination product?
A combination product is comprised of two or more regulated medical device components. This can be a drug/device, biologic/device, drug/biologic or drug/device/biologic. There are three defined types of combination products: single entity, co-packaged and cross labeled. Single entity combination products contain components that are physically, chemically or otherwise combined or mixed and produced as one entity. Examples of single entity combination products include a drug-eluting stent or insulin injector pen. Co-packaged combination products contain multiple products that are packaged together in one, single package or as a unit. Examples of co-packaged combination products include a drug vial and empty syringe or a first aid kit. Cross-labeled combination products contain multiple products that are packaged separately but specifically labeled to be used together. An example of a cross-labeled combination product is a photosensitizing drug and activating laser/light source.
There are also several instances that are often confused for combination products but do not meet the criteria. Some common instances include multiple quantities of the same drug, device or biologic; different products of the same product type; or a medical product and a non-medical product.
What are the U.S. FDA requirements for a combination product?
As mentioned, combination product requirements are not often straightforward. As a rule, the device constituent would have a UDI (Unique Device Identifier) identifier and the drug constituent would have an NDC (National Drug Code) identifier, therefore, a combination product would include both NDC and UDI identifiers. The chart below offers a more in-depth look at specific situations that may not align with our established rule of thumb.
| Combination PMOA | Combination Category | Combination Product ID | Drug Constituent ID | Device Constituent ID |
|---|---|---|---|---|
| Drug (CDER/CBER) | • Single-Entity | NDC | No NDC | No UDI |
| • Co-Packaged • Cross-Labeled |
NDC | NDC | UDI | |
| Device (CDRH) | • Single-Entity | UDI | No NDC | No UDI |
| • Co-Packaged • Cross-Labeled |
UDI | NDC | No UDI |
What are the key components of medical device and drug FDA regulations?
The FDA regulations for drug and devices are not the same in any case, but they very often mirror each other and serve as different means to the same end. This chart was created by Reed Tech to help guide customers through this process with an at a glance comparison.
| Attribute | Medical Device | Drug |
|---|---|---|
| FDA Center | CDRH | CDER, CBER, CVM |
| Premarket Approval | IDE, PMA, 510(k), De Novo, 510(k) Exempt, HDE and more | IND, NDA, ANDA, BLA, NADA, ANADA, OTC Monograph and more |
| Establishment Registration Fee | Device Facility User Fee (annual) | Various user facility fees (annual) |
| Establishment Registration | FURLS web entry (after approval/clearance) | SPL-ER file via ESG |
| Product Listing | FURLS web entry | SPL-LIST file via ESG |
| Product ID Reporting | UDI record submission to FDA GUDID | Product Listing populates FDA NDC Directory |
How can we comply with combination product requirements?
Reed Tech has long offered services to help Life Sciences companies comply with FDA medical device regulations and pharmaceutical regulations. We offer consultation and services to support the necessary combination product submissions, as well as data management services and more. For more information, contact Reed Tech at [email protected] or [email protected].