PS39: Regulatory Science Tools to Accelerate the Development and Evaluation of Medical Products

Open-source software plays a critical role across the lifecycle of medical product development, from early-stage research to regulatory evaluation and post-market analysis. Many recent advances in artificial intelligence and machine learning have been enabled by robust open-source ecosystems that have been able to lower barriers to innovation and promote transparency, reproducibility, and community validation. Within medical device development, publicly available statistical and computational tools-such as multi-reader multi-case (MRMC) analysis frameworks (Gallas et al. 2009)-are routinely used in pilot studies, pivotal trials, and FDA premarket review to support assessments of safety and effectiveness. However, the success of such tools is not guaranteed. Sustainable and impactful tools require well-defined use cases, thoughtful design choices, rigorous validation, clear documentation, and an engaged user and developer community, often supported through academic–industry–regulatory collaborations. In response to unmet analytical and methodological needs, the Office of Science and Engineering Laboratories (OSEL) in the Center for Devices and Radiological Health (CDRH) has led recent initiatives to develop and publicly disseminate regulatory science tools (RSTs), now catalogued in the CDRH Regulatory Science Tools Catalog (FDA CDRH 2026). These tools are intended to ease the development and evaluation of medical devices utilizing the latest regulatory science research, accelerating clinical innovation and commercial adoption. This session will first introduce the audience to the concept of regulatory science tools, featuring speakers from industry and the FDA who will demonstrate several recent tools and discuss their design principles, applications, and regulatory relevance. The session will conclude with a moderated panel discussion on the future of open-source tool development in regulatory science, addressing key questions such as: • What characteristics distinguish effective and useful tools? • How can existing tools evolve to better meet the needs of developers, reviewers, and researchers? • What are critical gaps in current tooling? This session aims to foster dialogue between tool developers, regulators, and the broader research community to encourage collaborative development of next-generation regulatory science tools that support safe, effective, and timely medical innovation.