Division of Clinical Research

Office of the Vice President and Innovation

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 catalogue here: https://www.fda.gov/medical-devices/science-and-research-medical-devices/catalog-regulatory-science-tools-help-assess-new-medical-devices?utm_medium=email&utm_source=govdelivery

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.

Categories FDA Regulatory

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