Life Sciences Insight

FDA Adds New Regulatory Science Tools for Assessing Medical Devices

FDA recently added five tools to its catalog of regulatory science tools to help assess medical devices, including phantoms and laboratory methods. Here is a brief description of each new tool, along with a reference link for more information. This catalog collates a variety of over 80 regulatory science tools developed by the Office of Science and Engineering Labs (OSEL) in FDA’s Center for Devices and Radiological Health. OSEL plans to continue to expand the catalog as new tools become available.

  • Phantom for assessing performance of near-infrared hematoma detectors: A modular, polymer phantom approach that enables evaluation of the performance of hematoma detectors using wavelengths close to the 805 nm isosbestic point of hemoglobin. This tool is used for assessing devices in the area of medical imaging and diagnostics. Click here for more information.
  • 3D-printed phantom material and design with tissue-relevant Raman signature: A tool for performing Raman spectroscopy measurements on a well-characterized 3D-printed sample that has tissue-simulating optical properties. This tool is also used for assessing devices in the area of medical imaging and diagnostics. Click here for more information.
  • Digital models of retinal vasculature based on a clinical fundus camera image: Digital model available on NIH’s 3D Print Exchange site that can be used to fabricate tissue simulating phantoms with biomimetic vascular structures derived from a clinical image. Click here and here for more information, or click here for the digital model.
  • Multifunctional method for quantitative evaluation of time-dependent eye hazard from laser pointers: A multifunctional test method for quantification of underreported transient fluctuations in critical radiant power characteristics for multiwavelength laser pointers for evaluation of potential eye hazards. Click here for more information.
  • Battery of image quality test methods for evaluation of fluorescence imaging systems. Click here for more information.
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