Combination Products

In addition to medical device regulation, the FDA also regulates food, drugs, vaccines, blood and biologics, animal and veterinary products, cosmetics, radiation emitting products and tobacco products. With respect to medical and healthcare products, the three main FDA centers for regulation are:
• CDRH: Center for Devices and Radiological Health
• CBER: Center for Biologics Evaluation and Research
• CDER: Center for Drug Evaluation and Research

In some cases, a therapeutic or diagnostic product might combine drugs, devices, and/or biological products. The FDA classifies these products as combination products. This may be,
(i) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity; or
(ii) Two or more separate products packaged together in a single package or as a unit.
Example: Drug eluting stent - It combines device and drug.

In such scenarios, it is essential to determine which FDA center gets jurisdiction of the product. It is usually determined by two main questions:
– What is the primary mode of action of the product?
– Is it a drug, biologic, or device?
If there still is any confusion, the FDA allows the manufacturer to submit a Request For Designation (RFD) form, so that the FDA can decide the primary jurisdiction for the combination product. This is to be done before filing any other device-related document to the FDA. The FDA considers the
• Primary Mode of Action
• Previous Determinations for Precedent and
• Sponsor's request with a justification
before it makes a determination.
Example: In the case of a drug eluting stent, it was classified primarily as a device, since its primary mode of action is to prevent localized vessel/flow constriction. The drug is eluted as a secondary action to prevent fibrosis and eventually re-stenosis. Hence, the product was primarily assigned to CDRH and was to consult CDER as well.