The FDA has definitions for what constitutes a drug, a biologic, and a medical d

Question

The FDA has definitions for what constitutes a drug, a biologic, and a medical device. However, there are times when marketing approval is sought for products that combine two or more of these, such as skin patches that deliver drugs or drug eluting stents. These products are referred to as combination products.

Question:- How to determine if a product is a combination or non-combination product and the process you would go through to determine what a company should focus on during the approval phase?.

Explanation / Answer

(1) 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;

(2) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;

(3) 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 where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or

(4) Any investigational drug, device, or biological product packaged separately that according to its proposed labeling 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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