Charge to the Medical and Biological Engineering Review Subcommittee of the FDA Science Board
Regulatory science, the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products, is a major area of emphasis for the FDA. Throughout industry and academia the coordination of life science and engineering has become a strategic prerequisite to successful product-oriented innovation. The FDA has an opportunity to accelerate the impact of regulatory science if it can simultaneously harness the engineering involved. Indeed, regulatory science and engineering together are what will change the landscape of the regulatory process. The Medical and Biological Engineering Review Subcommittee of the FDA Science Board will review the degree to which engineering expertise is integrated into FDA programs. The Subcommittee will not focus specifically on CDRH activities, but on Agency-wide engineering activities and capacities, including relevant information from CDRH obtained in coordination with the CDRH review subcommittee, with which it will have 2 joint members. Once the current status of engineering at the agency is determined the Subcommittee will be in a position to recommend potential opportunities for appropriate enhancements, including any enhancements that could be made with existing resources. The Subcommittee will also advise on how the FDA can take advantage of the rapidly expanding network of bioengineers across the nation.
Charge to the Science Board: FDA requests the Science Board to work with its regulatory scientists and engineers, FDA’s scientific leadership and with other internal and external stakeholders to understand both current and projected FDA activities utilizing engineering sciences and to identify future opportunities to utilize and integrate medical and biological engineering activities and expertise in enhancing performance of the FDA’s mission to protect and promote public health.
The product of this review of FDA’s engineering capacity, infrastructure and expertise will be a report from the FDA Science Board that will include findings and recommendations that address the following issues or questions:
- What distinct engineering activities at FDA contribute to the acceleration and public health outcomes of the regulatory review process?
- Identify important scientific gaps or imbalances in engineering expertise and technological capability in which FDA should, where feasible, increase efforts to ensure that it can address the current and future demands of its regulatory and public health roles.
- What potential opportunities are there to enhance FDA’s engineering infrastructure capacity, and collaborations, including with existing resources, that would best support regulatory activities for emerging science and regulatory needs?
- What progress has FDA made to date to develop intramural and extramural regulatory science and engineering capabilities and approaches that will ensure that engineering related or enabled regulatory tools, processes and standards are not unnecessarily limited or delayed by a sequential approach to development and implementation?
- Identify opportunities to leverage the FDA’s engineering activities and advance related regulatory science through partnerships with institutions and organizations of the broader engineering community.
- Assess and suggest any needed enhancements to FDA’s ability to recruit, develop, and retain the engineering expertise needed to address current and future regulatory science challenges?