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FDA

FDA Compliance

Piloting an Improved Intercenter Consult Process

The future of medical product development?

Published: Thursday, August 11, 2016 - 12:06

(FDA: Washington, DC) -- During the last few months, we’ve shared what the 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 FDA 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, etc.) covered by more than one FDA product center. As such, close intercenter collaboration and communication are important to facilitate timely, appropriate, 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 combination products, and issuing and completing consults needed to support the review.
• Developing a tiered consult approach that streamlines interactions across centers and identifies a clear process for identifying the right experts for a consult.
• Defining clear roles and responsibilities for the lead center, the consulted center(s), the Office of Combination Products (OCP), and the Combination Product Council for review of a combination product submission.
• Creating a standard, semi-automated, user-friendly ICCR form that is managed electronically to ensure that, first, users always have the most updated version; and second, that all forms, and thus all intercenter combination product consults, are tracked through a single system.

The FDA will begin piloting this new ICCR process today in select offices within our three medical product centers, focusing on those offices or divisions that routinely receive combination product submissions that require cross-center consults. The pilot will be comprised of three phases, with phase 1 planned to last for two months. Additional offices in each center will be rolled into the pilot in subsequent phases with the goal of achieving implementation across all offices by the end of June, 2017.

During each phase of implementation, we will collect quantitative and qualitative data to evaluate success. What we learn at each stage will allow us to refine processes, procedures, and training for subsequent phases. In particular, data from phases 1 and 2 will be used largely to refine the initial steps of the ICCR process (e.g., consult request, ICCR form, and reviewer assignment), although some limited consult completion data (e.g., consult quality and timeliness) available for Investigational Device Exemptions/Investigational New Drugs may provide initial insights on consult closeout. Consult completion data for other submission types will also be collected but may not be available for several months due to the longer submission review timelines.

This iterative approach will ensure implementation of a robust ICCR process that enables efficient, effective collaboration on the review of combination products. Further, auditing regarding combination product designation and consult tier assignment completed by each center will verify effective knowledge transfer or highlight gaps to focus on in subsequent improvement efforts.

This current effort has been driven by a cross-agency ICCR working group and builds on the important work of many others across the FDA.

We hope this overarching approach to cross-center activity will, if successful, serve as a flagship model for other cross-agency initiatives requiring close collaboration. We believe that this kind of nimble, adaptive cooperation reflects the future of medical product development and review in an increasingly complex and nuanced arena. Stay tuned—we plan to keep you updated on our progress along the way. Meanwhile, if you have any feedback or input, please feel free to contact us at: combinationproductICCRpilot@fda.hhs.gov.

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FDA

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.