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A combination product, as defined in 21 CFR § 3.2(e), is a product comprised 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 .
Some products are used together in a way that does not meet the regulatory definition of a combination product, but that may raise similar development or regulatory issues.
These kinds of products may include the concomitant use of drugs, devices, and/or biological products that are not “individually specified” in the product labeling (see 21 CFR 3.2(e)(3)); and combinations of drugs, devices and/or biological products with other types of FDA-regulated articles, such as dietary supplements, cosmetics, or foods.
This website will provide links to information on recently approved products of this type and other related information in an effort to keep stakeholders informed.
Examples of These Types of Products
Related Information:
FAQ – How are products that combine a drug and a cosmetic regulated?
FAQ – How are products that combine a drug and a dietary supplement regulated?
FAQ – How are products that combine two or more drugs regulated?
Dietary Supplements
Cosmetics
Is It a Cosmetic, a Drug, or Both? (or Is It Soap?)
CDER – Information About the Drugs We Regulate
CDRH - Device Advice
CBER – Manufacturers Assistance