Originally Published MX May/June 2003

BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT

Advances in medical technology lead to increasingly complex products being submitted to FDA for review. Creative combinations of drugs, biologics, and devices have accordingly caused the regulatory agency to rethink its jurisdictional approach to the review process. A combination product is defined in the Code of Federal Regulations (21 CFR 3.2 (e)) as any of the following:

• A product comprising 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.
• Two or more separate products packaged together in a single package or as a unit and comprising drug and device products, device and biological products, or biological and drug products.