Catalog of Regulatory Science Tools to Help Assess New Medical Devices | FDA

Catalog of Regulatory Science Tools to Help Assess New Medical Devices | FDA

FDA Posts Regulatory Science Tools to Help Assess New Medical Devices

The U.S. Food and Drug Administration (FDA) posted to our website a catalog of regulatory science tools to help assess new medical devices. 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 and plans to expand as new tools become available.  The tools include: Laboratory methods Computational models and simulations Physical and virtual phantoms  These tools expand the scope of innovative science-based approaches to help improve the development and assessment of emerging medical technologies. We have provided references for each tool. These tools do not replace FDA-recognized standards or qualified medical device development tools (MDDTs). The FDA has not evaluated the suitability of these tools within any specific context of use.

View Catalog Questions? If you have questions about this catalog of regulatory science tools, email OSEL_CDRH@fda.hhs.gov.