Combination Products for Medical Device Developers

What’s In This Tech Brief

Combination products are defined in 21 CFR 3.2(e) as therapeutic and diagnostic products 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. This broad definition includes products ranging from pre-filled syringes to drug coated implants. In this brief, the focus is on implanted devices. For medical device companies, combination products provide an attractive route to improving product performance or extending a product’s lifecycle. However, the inclusion of a drug also introduces new development and regulatory considerations.

In this technical brief, we focus on:

• Types of combination products and production processes
• How the addition of drugs to existing medical devices can enhance their performance
• Key considerations associated with combination product development and regulatory pathways