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FDA adds 25 regulatory science tools to help assess medical devices

The U.S. Food and Drug Administration (FDA) added 25 tools to the Catalog of Regulatory Science Tools to help assess medical devices. The tools include:

  • Laboratory Accuracy Evaluation of Infrared Thermographs
  • Benchmark Problems for Verifying Cardiac Electrophysiological Models
  • Use of Newtonian Analog Fluids And 3D Printing to Evaluate Flow Rates of Diets In G-Tubes
  • Confocal Laser Methods (CLM) For Quantitative Evaluation of Dioptric Power Characteristics of Intraocular Lens (IOL) Implants
  • Mammoreplicator Software Tool to Create 3D Printed Phantoms
  • Wireless Coexistence (multiple tools)

This catalog collates a variety of 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.

View Catalog

These tools expand the scope of innovative science-based approaches to help improve the development and assessment of emerging medical technologies. The catalog includes references for each tool. These tools do not replace FDA-recognized standards or qualified medical device development tools. The FDA has not evaluated the suitability of these tools within any specific context of use.

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