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 (RST) is a computational method that employs conditional denoising diffusion probabilistic model (DDPM) to generate synthetic histopathology images guided by nuclei segmentation masks, helping to augment limited annotated whole slide image (WSI) datasets for AI model development and validation in digital pathology.
T-SYNTH is a synthetic dataset of paired DM (2D imaging) and DBT (3D imaging) images derived from a Knowledge Based (KB) model, with lesion bounding boxes and pixel-level tissue segmentations of a variety of breast tissues.
The Pediatric IQ Phantoms tool is a dataset of virtual image quality phantoms in a range of diameters and their computed tomography (CT) images for assessing pediatric generalizability of CT denoising devices.
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.