Introduction to FDA Regulation of Combination Products

Overview:

A combination product is a product composed 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.

Under 21 CFR 3.2 (e), a combination product is defined to include:

• 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;
• 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;
• 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
• 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

Why you should Attend:

To gain a fundamental understanding of FDA regulation of bioresearch monitoring.

Areas Covered in the Session:

• Definition of combination product
• FDA Regulatory Pathways
• Primary Mode of Action
• User Fee

Who Will Benefit:

• Regulatory professionals working in the field of combination products