A combination product is a product consist of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.
As per FDA 21 CFR 3.2, a combination product is defined as
- A product consist of two or more elements for example, drug/device, biologic/device, drug/biologic or drug/device/biologic that are physically, chemically combined to form a single unit which is often referred as “single-entity” combination product. Some examples of single entity combination products are Syringes, insulin injector pen metered dose inhalers.
- Two or more products packaged together in a single packet or as a package that has drug/device products, device/biologic products or biologic/drug products are often referred as “co-packaged” combination product. Examples of co-packages combination products are first aid kits containing devices(band aids and gauze) and drugs (antibiotic ointments and pain killers)
- A drug/device/biological product packaged separately that as per the label it is intended for use only with an approved individually specified drug/device/biological product, where both are required to attain the intended use and upon the approval of proposed product, the labeling of the approved product needs to be changed are referred as “cross-labeled” combination product. Examples of cross-labeled combination product is Photosensitizing drug and activating laser/light source
- Any investigational drug/device/biological products packaged separately and as per its proposed labeling it can be used only another individually specified investigational drug/device/biological product where both are required to have the same intended use which are referred as another type of “cross-labeled” combination product.
Section 503(g) (1) of FD&C act requires FDA to assign a component of the agency to primary jurisdiction for the regulation of combination product. The assignment of jurisdiction is based on the “primary mode of action” of the combination product. For example, if the primary mode of action of a combination product is a biological product, then it is assigned to FDA component which is responsible for the premarket review of that biological product.
Combination products are marketed under an authorization type connected with the constituent part that gives the primary mode of action (PMOA) for the combination product. For example, it should have NDA or ANDA if it has drug PMOA, a biologic license application (BLA) if it has a biologic PMOA or PMA (Pre-market approval) or 510K clearance if it has a device PMOA.
GMP requirements are applicable to all combination products that has drug/device/biologic constituent part.
Liberty Management Group, a leading FDA consulting firm in the United States will provide assistance with FDA registration of combination products.
Sudha S
Regulatory Consultant
Mail : office@libertymanagement.us