Combination products: Overview, definition, and example
What are combination products?
Combination products refer to products that consist of two or more different types of components, typically combining a drug, device, and/or biological product in one package. These products are designed to achieve a therapeutic effect by integrating different technologies or approaches. For example, a combination product might involve a drug that is delivered via a device, or a biologic product that works in conjunction with a medical device.
Combination products are commonly used in the healthcare industry, particularly in pharmaceutical, biotechnology, and medical device sectors. They require unique regulatory oversight because they combine elements that would normally be separately regulated (drugs, biologics, or devices).
Why are combination products important?
Combination products are important because they provide more efficient, effective, and patient-friendly treatments. By combining multiple therapies or technologies, these products can address specific medical needs more effectively than individual components used separately. For instance, a combination product might improve drug delivery, enhance patient compliance, or provide new ways to treat complex diseases.
For businesses, understanding combination products is crucial for compliance with regulatory requirements and ensuring that these products meet safety and effectiveness standards before they can be marketed.
Understanding combination products through an example
An example of a combination product is an insulin pen, which combines a pre-filled insulin cartridge (a drug) and a delivery device (the pen) in one product. The insulin pen allows patients with diabetes to easily administer their insulin dosage, combining the therapeutic effect of the drug with the convenience of the delivery device.
Another example is a drug-eluting stent, which is a small medical device (the stent) that is coated with a drug to prevent artery restenosis (narrowing). This combination product combines the mechanical function of the stent with the drug’s therapeutic effect.
An example of a combination products clause
Here’s how a combination products clause might appear in a regulatory or product development agreement:
“The Parties agree that the product developed under this Agreement will be classified as a combination product, consisting of a [drug/biologic] and [device]. The Parties will ensure that the product meets all regulatory requirements set forth by [regulatory authority] for combination products and will collaborate on testing, approval, and marketing activities.”
Conclusion
Combination products combine two or more different components, such as a drug, device, or biologic, into a single product designed to address specific medical needs more effectively. These products play an important role in improving patient care by offering more integrated solutions for complex health issues. For businesses, understanding the regulations and potential benefits of combination products is key to developing effective, compliant products in the healthcare market.
This article contains general legal information and does not contain legal advice. Cobrief is not a law firm or a substitute for an attorney or law firm. The law is complex and changes often. For legal advice, please ask a lawyer.