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.
A method to assess texture reproduction of camera-phone-based medical devices with a dead leaves target
MC-GPU is a Monte Carlo simulation code that can generate synthetic radiographic images and computed tomography (CT) scans of realistic models of the human anatomy using fast Graphics Processing Unit (GPU) cards.
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
This regulatory science tool presents a computer model to assist investigators with analyzing and sizing multi-reader multi-case (MRMC) reader studies that compare the difference in the area under Receiver Operating Characteristic curves (AUCs) from two modalities.
A mathematically easy to understand and experimentally simple method to quantitatively and objectively evaluate endoscope geometric distortion
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
A software program written in Matlab for analyzing color performance testing data in endoscopy devices