Combination products present regulatory challenges because their constituent parts must be reviewed by more than one agency center. Under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act, combination products are assigned to a lead center based on their primary mode of action. The lead center then consults with other centers that oversee one or more of the product’s constituent parts. Recognizing the need for more timely and consistent consults, the FDA recently initiated Phase 1 of its new intercenter consult request (ICCR) process for combination products.
FDA Rolls Out Intercenter Pilot Project
Designed to address the recommendations for improvement made by a study team from the Office of Planning, Phase 1 of the ICCR pilot project is currently being rolled out in select offices within three medical product centers and will last for two months. The FDA expects full implementation to be completed by the end of the second quarter of 2017.
Objectives of the Pilot Project
The ICCR pilot project aims to:
- Establish timelines, specific to submission type and agency center, for identifying combination products and completing the consults required to support submission reviews.
- Develop a tiered approach to consults that streamlines interactions across agency centers and creates a clearer process for identifying suitable experts for consults.
- Define clearer roles and responsibilities for the lead agency center, the consulted agency centers, the Office of Combination Products and the Combination Product Council.
- Create a standard, semi-automated ICCR form that is managed electronically, updated regularly and tracked through a single system.
The FDA will collect data at each phase to monitor and evaluate progress against these objectives, and refine procedures, processes and training for subsequent phases.
If successful, the project will improve intercenter communication and collaboration to create a more streamlined and efficient combination product submission review process. It will also serve as a model for other FDA cross-agency initiatives.
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