Glossary Term
Combination Products
Definition
Combination Products are therapeutic and diagnostic products that combine two or more regulated components, such as drugs, devices, and/or biologics, into a single entity or system. Examples include drug-eluting stents, pre-filled syringes, and photodynamic therapy devices. These products are regulated under a unique framework that incorporates elements of drug, device, and biologic regulations.
Relevance to the MedTech Industry
Combination products address complex medical needs by integrating the benefits of multiple therapeutic modalities into a single solution. They provide innovative treatments and diagnostic options that enhance patient outcomes, streamline care delivery, and expand the capabilities of traditional medical technologies.
Additional Information & Related Terms
Drug-Eluting Stent (DES) A common type of combination product.
Biologic Product Often integrated into combination products for advanced therapeutic effects.
Regulatory Compliance Ensures combination products meet multi-faceted regulatory standards.
ISO 13485 Quality management standards applicable to the device components of combination products.