On May 13, 2024, FDA’s Office of Science and Engineering Laboratories (OSEL) launched an improved online Regulatory Science Tool (RST) Catalog to enhance search and browse capability as well as allow for long-term growth in published tools. The RST Catalog is now organized by research program and device type, cross referenced by both program and RST category, and an online portal for many OSEL-developed applications including the Device and Material Safety Evaluation Library. The RST Catalog will continue to provide peer-reviewed resources for medical device companies and innovators.
A Catalog of Regulatory Science Tools (RSTs) was developed by OSEL to expand the scope of science-based approaches used in the development of emerging medical technologies. These RSTs can be used by the industry to drive innovation and assess emerging medical technologies. The Catalog includes more than 100 RSTs, including laboratory methods, tissue-mimicking phantoms, and computational modelling and simulations. These tools are intended to add speed and consistency to medical device development by streamlining the review process. However, the introduction to the Catalog states these RSTs do not replace FDA-recognized standards or qualified medical device development tools (MDDTs) since they have not been evaluated for suitability to any specific use.
View the new Regulatory Science Tool Catalog here.
