FDA Adds 5 Regulatory Science Tools to Help Assess Medical Devices

The U.S. Food and Drug Administration (FDA) added 5 tools to the Catalog of Regulatory Science Tools to help assess medical devices. This catalog collates a variety of over 80 regulatory science tools developed by the Office of Science and Engineering Labs (OSEL) in the FDA’s Center for Devices and Radiological Health (CDRH). New tools include:

  • Phantom for assessing the performance of near-infrared hematoma detectors
  • 3D printed phantom material and design with tissue-relevant Raman signature
  • Digital models of retinal vasculature based on a clinical fundus camera image
  • Multifunctional method for quantitative evaluation of time-dependent eye hazard from laser pointers
  • Battery of image quality test methods for evaluation of fluorescence imaging systems

Click here to view the catalog: 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

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