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 software program written in Python for analyzing whole slide images (WSIs) and assisting developers or pathologists in the assessment of machine learning algorithms used in digital pathology.
This regulatory science tool is a synthetic mammography dataset that includes a variety of breast densities, breast sizes, and inserted lesions imaged with different exposure levels. The dataset is intended to be used for the comparative evaluation of AI tools used in mammography.
This regulatory science tool presents a method (web-based decision tree) that may help developers select appropriate metric and endpoint for Artificial Intelligence (AI) / Machine learning (ML) classification algorithms in medical imaging.
Tools that quantify wait-time-saving benefits for cases with positive diagnoses due to the adoption of Computer-Aided Triage and Notification devices in a radiology workflow
Statistical tools (java GUI and R package) to analyze, size, and simulate multi-reader multi-case (MRMC) reader studies