The FDA recently announced the addition of 25 new tools to the Catalog of Regulatory Science Tools to help assess medical devices. CDRH catalogues regulatory science tools on this webpage to help improve the development and assessment of emerging medical technologies.
Of the 25 tools added, some items of interest are:
- 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)
Of course, just because a tool is on the list does not mean that it is approved by the FDA for any specific context of use. Manufacturers must continue to use tools in compliance with FDA-recognized standards or qualified medical device development tools (MDDTs).