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.
Registration-based Automated Matching and Correspondence (RAMAC) is a tool that automatically identifies corresponding locations of landmarks across multiple images.
This regulatory science tool is an AI model tool used for developing and evaluating deep learning-based survival models.
DxGoals is a freely-accessible, RShiny software application that is intended to determine and visualize performance goals for common diagnostic test classification accuracy metrics including sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio. Model outputs are dependent on user inputs of desired risk stratification (pre- and post-test probabilities of the target condition). The tool also analyzes whether goals are met with statistical significance.
- Github Webpage: https://github.com/DIDSR/DxGoals
- Link to Software: https://fda-cdrh-osel-didsr-rst.shinyapps.io/DxGoals/
This regulatory science tool is a computer model intended to support evaluation of photon counting detectors (PCDs) during the product development phase by generating in-silico X-ray projections of computational anatomical models detected by PCDs.
sFRC (scanning Fourier Ring Correlation) is a tool that compares radiological images from AI or iterative-based image restoration algorithms against those from standard-of-care analytical algorithms to identify and label hallucinations (aka fakes) using small red bounding boxes, which serve as visual indicators of the detected hallucinations.
The Virtual Imaging Clinical Trials for Regulatory Evaluation (VICTRE) computer modeling pipeline is a set of tools that allow for the replication of clinical trials of in silico breast radiographic images for the evaluation of digital mammography (DM) and digital breast tomosynthesis (DBT) devices.
The Virtual Family provides detailed three-dimensional computational models of the human anatomy including an adult male, an adult female, and two children
A tool to generate computational scientific evidence as alternative approaches to clinical
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.
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 software program written in Matlab for analyzing color performance testing data in endoscopy devices