FDA adds 14 Regulatory Science Tools to help assess medical devices
The U.S. Food and Drug Administration (FDA) added 14 tools to the Catalog of Regulatory Science Tools to help assess medical devices, including laboratory methods and computational models and simulations.
This catalog collates a variety of regulatory science tools developed by the Office of Science and Engineering Labs (OSEL) in the FDA’s Center for Devices and Radiological Health (CDRH). OSEL plans to continue to expand the catalog as new tools become available.
These tools expand the scope of innovative science-based approaches to help improve the development and assessment of emerging medical technologies. The catalog includes references for each tool. These tools do not replace FDA-recognized standards or qualified medical device development tools. The FDA has not evaluated the suitability of these tools within any specific context of use.
