Regulatory Science Tools Catalog
The Regulatory Science Tools Catalog provides a peer-reviewed resource for use where standards and qualified Medical Device Development Tools (MDDTs) do not yet exist. These tools do not replace FDA-recognized standards or MDDTs. This catalog collates a variety of regulatory science tools that the FDA's Center for Devices and Radiological Health's (CDRH) Office of Science and Engineering Labs (OSEL) developed. If you are considering using a tool from this catalog in your marketing submissions, note that these tools have not been qualified as Medical Device Development Tools and the FDA has not evaluated the suitability of these tools within any specific context of use. You may request feedback or meetings for medical device submissions as part of the Q-Submission Program.
This regulatory science tool is a method and phantom design for the evaluation of iodine-specific quantitative measurements, specifically the accurate estimation of iodine concentration within contrast-enhanced spectral CT.
This regulatory science tool is a lab method that computes bone microstructure metrics to characterize bone morphology and skeletal geometry.
Test methods that provide a practical approach for objective, quantitative evaluation/comparison of fundamental performance in near-infrared fluorescence imagers.
A method to assess texture reproduction of camera-phone-based medical devices with a dead leaves target
Tool for assessing image quality of advanced nonlinear CT image reconstruction and denoising products, including but not limited to statistical iterative, model-based iterative, and deep learning-based methods
Best practices for standardized performance testing of infrared thermographs intended for fever screening
A mathematically easy to understand and experimentally simple method to quantitatively and objectively evaluate endoscope geometric distortion