White Paper: Medical

Combination Products for Medical Device Developers

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Combination products are thera¬peutic and diagnostic products comprising two or more regulated components (drug, device, or biologic) that are com¬bined or mixed and produced as a single entity. 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 how the addition of drugs to existing medical devices can enhance their performance. We will also explore the key considerations associated with combination product development and regulatory pathways.

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