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Combination Products

What are Combination Products?

Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. Because combination products involve components that would normally be regulated under different types of regulatory authorities, and frequently by different FDA Centers, they raise challenging regulatory, policy, and review management challenges. Differences in regulatory pathways for each component can impact the regulatory processes for all aspects of product development and management, including preclinical testing, clinical investigation, marketing applications, manufacturing and quality control, adverse event reporting, promotion and advertising, and post-approval modifications.

Examples of combination products include a device coated or impregnated with a drug or biologic such as a catheter with antimicrobial coating or wound healing patch, or a prefilled drug delivery system, such as syringes or insulin injector pen.

Since it is not always clear which center is the primary reviewer for combination products, the Office of Combination Products (OCP) was created to serve as a focal point for combination product issues and for medical product classification. The OCP develops guidances and regulations to clarify the regulation of combination products. They also assign the FDA center for premarket review and regulation, where product classification or assignment may be unclear.

Combination products are assigned to a FDA center that will have primary jurisdiction for premarket review and regulation. According to section 503(g)(1) of the Act, assignment to a lead center with primary jurisdiction for premarket review and post-market regulation is based on a determination of the “primary mode of action” (PMOA) of the combination product. Section 503(g) defines primary mode of action as “the single mode of action of a combination product that provides the most important therapeutic action of the combination product.” If you are unsure of the PMOA for your combination product, you may request formal assignment through FDA’s Request for Designation (RFD). Folio Consulting Group, LLC can help you prepare this request and additional FDA Guidance on How to Write a RFDs is available here.  

Fortunately, for combination products only 1 premarket application is required. The type of marketing authorization submission is dependent on the PMOA for the product. For a combination product where the PMOA is a drug for a new drug application (NDA) or abbreviated new drug application (ANDA) would be required. For a biologic PMOA, a biologic license application (BLA) would be required. For a medical device PMOA, a premarket approval application (PMA), de novo classification request, or premarket notification [510(k)] would be required. Contact Folio Consulting Group, LLC today for help determining your regulatory strategy and what marketing authorization submission is required.

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