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

5 tools, including phantoms and laboratory methods, have been added.

If your email program has trouble displaying this email, view as a webpage. FDA Adds 5 Regulatory Science Tools to Help Assess Medical Devices The U.S. Food and Drug Administration (FDA) recently added 5 tools to the Catalog of Regulatory Science Tools to help assess medical devices, including phantoms and laboratory methods: Phantom for assessing 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 View Catalog 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). 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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