Piloting an improved intercenter consult process

By: Michael Rappel, Ph.D., and Rachel E. Sherman, M.D., M.P.H. Over the last few months, we’ve shared what FDA is doing to improve the review of combination products, including establishing the Combination Product Council and identifying necessary process improvements through lean mapping of the combination product review process. We are pleased to update you on the proposed intercenter consult request (ICCR) process that will be piloted across the Agency today. Combination products—those that combine drugs, devices, and/or biological products—present both policy and review challenges in large part because they include constituent parts that fall into more than one regulatory category (e.g., drug and device; drug and biologic) covered by more than one FDA product center. As such, close intercenter collaboration and communication are important to facilitate timely, appropriately-tailored and well-informed submission review. A combination product will generally have a lead center which may seek consults from the other centers that oversee one of the product’s constituent parts. Timely and consistent consults are critical, yet achieving this has been challenging due to different policies, practices, and timelines for consults across centers and insufficient communications between centers and sponsors. Our new process addresses these issues with four important improvements: Establishing timelines, specific to center and submission type, for identifying products as combin...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Blog FDA Source Type: news