Catalog of Regulatory Science Tools to Help Assess New Medical Devices
Update: January 12, 2024: The FDA is providing an updated Regulatory Science Tool (RST) Catalog that will provide additional tool search capability allow for additional capacity as the catalog continues to grow.
About the catalog of regulatory science tools
The Catalog of Regulatory Science Tools provides a peer-reviewed resource for medical device companies to use where standards and qualified Medical Device Development Tools (MDDTs) do not yet exist. These tools do not replace FDA-recognized standards or MDDTs. This catalog collates a variety of regulatory science tools that the FDA's Center for Devices and Radiological Health's (CDRH) Office of Science and Engineering Labs (OSEL) developed. These tools use the most innovative science to support medical device development and patient access to safe and effective medical devices. If you are considering using a tool from this catalog in your marketing submissions, note that these tools have not been qualified as Medical Device Development Tools and the FDA has not evaluated the suitability of these tools within any specific context of use. You may request feedback or meetings for medical device submissions as part of the Q-Submission Program.
For more information about the Catalog of Regulatory Science Tools, email OSEL_CDRH@fda.hhs.gov.