To facilitate the expanded use of innovative science techniques in the development of new medical device technologies, the U.S. Food and Drug Administration (FDA) has published a collection of regulatory science tools that can be used to assess emerging medical technologies for compliance with its requirements.
The Catalog of Regulatory Science Tools was assembled by the FDA’s Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Laboratories (OSEL) and posted to the FDA’s website in late March. The Catalog includes details on dozens of methods, computational models and simulations, and phantoms that medical device manufacturers can use to assess their devices for safety and performance.
The FDA says that the Catalog will be expanded and updated as new tools become available. Importantly, the agency also notes that the tools in the Catalog do not replace FDA-recognized standards or qualified medical device development tools.