Medical Device Link.

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.
• A drug, device, or biological product packaged separately that, according to its investigational plan or proposed labeling, is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and that will be labeled as such upon approval.
• Any investigational drug, device, or biological product packaged separately that is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.

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