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 an open-access dataset containing adaptive optics – optical coherence tomography (AO-OCT) images of the outer retina, along with the cell markings and topographical characterizations of the retinal pigment epithelium (RPE) cells and photoreceptor (PR) mosaics across the temporal macula from healthy individuals. This RST can serve as a normative baseline for future studies of retinal pathology and as labelled ground truth data for the assessment of novel algorithms for automated PR/RPE cell segmentation.
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 (RST) is a dataset of whole slide images and pathologist annotations for use in the development of new statistical methods.
This regulatory science tool (RST) is a dataset of facial and oral temperatures collected from infrared thermography of more than1000 human volunteers that may be helpful in evaluating the performance of thermal imaging systems and thermometers.
This regulatory science tool (RST) serves as a reference dataset summarizing the engineering characteristics for orthopedic bone fixation devices (plates and screws) in pediatric patients.
This regulatory science tool is an open-access dataset containing raw inertial measurement unit (IMU) and sensorized insole data from individuals with Parkinson’s Disease (PD) and age-matched controls synchronized to a gait walkway reference system that can serve as a tool to assess novel algorithms deriving gait metrics through wearables and explore measurable connections between gait, PD severity, PD progression, and controls, thus leading to future clinical enhancements and treatments for patients.
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 an open-access dataset tool for the assessment of wearable technology deriving gait parameters.
Chemicals List for Analytical Performance (CLAP)
This tool provides a benchmark validation data set for laminar flow in an anatomical vascular model of the inferior vena cava (IVC).
This RST is a database tool consisting of nine mock circulation loop (MCL)-generated datasets for characterizing three dynamic attributes of pressure-based cardiac output monitoring systems that apply an algorithm to intra-radial arterial blood pressure waveforms for cardiac output and stroke volume variation measurements.
The DAMSEL tool is a digital collection of published information related to the safety profile of materials commonly used in the manufacture of medical devices. This interactive application allows users to filter and access key response data for studies relating to material biocompatibility along with hyperlinks to the relevant original studies.
A "threshold-based" validation approach that provides a well-defined acceptance criterion, which is a function of how close the simulation and experimental results are to the safety threshold, for establishing the model validity.