FDA Updates Catalog of Regulatory Science Tools to Help Assess Medical Devices

7 tools, including phantoms, laboratory methods, and models, have been added.

If your email program has trouble displaying this email, view as a webpage. FDA Adds 7 Regulatory Science Tools to Help Assess Medical Devices The U.S. Food and Drug Administration (FDA) recently added 7 tools to the Catalog of Regulatory Science Tools to help assess medical devices, including phantoms, laboratory methods, and models: Approach to validate simulation-based distributions: Application to focused ultrasound Electrophysiological biomarkers of brain injury High electric-field generator for MRI safety testing Microcalcification templates o2S2PARC: Open online simulations for stimulating peripheral activity to relieve conditions Parchment breast phantom Transfer function measurement method for implanted leads View Catalog This catalog collates a variety of 89 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. Questions? If you have questions about this catalog of regulatory science tools, email OSEL_CDRH@fda.hhs.gov.

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