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.
This regulatory science tool (RST) is a software suite that can assist with the objective task-based assessment of digital breast tomosynthesis (DBT) systems imaging performance that uses CDMAM 4.0 phantom and a deep learning (DL) model observer. The RST includes a set of Python scripts, a pre-trained baseline model, and the user’s manuals.
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.
This regulatory science tool is a lab method that can be used for the assessment of agreement in overlap-based performance between an AI segmentation device and a multi-expert human panel.
This regulatory science tool (RST) is a software framework for generating hybrid breast CT images that combine simulated microcalcification clusters with real patient breast CT projection data.
Geometric Distortion Measurement Method on Video See-Through Augmented Reality Head-Mounted Displays
This regulatory science tool (RST) is a laboratory method for measuring the geometric distortion of the physical space observed with video see-through (VST) head-mounted displays (HMDs).
Tools that quantify wait-time-saving benefits and delays for patients with positive diagnoses across various disease conditions due to the implementation of multiple Computer-Aided Triage and Notification devices in a radiology workflow.
This regulatory science tool is a software for evaluating the calibration of models with probabilistic output.
This regulatory science tool is a laboratory method for the evaluation of contrast perception on head-mounted displays.
MRI-IQ-ETK is a software toolkit that contains digital test phantom generation and automated image quality evaluation components intended to help assess the performance of MRI image reconstruction methods.
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 lab method developed to assist end users in printing accurate Monk skin tone (MST) scales with consumer-grade color printers.
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 Laboratory Method outlining the use of a hydrogen peroxide solution to screen for oxidative degradation. This method allows for maintenance, monitoring and reporting of solution concentration and oxidative capacity and (iii) is demonstrated with UHMWPE as a non-resorbable polymer susceptible to oxidative degradation.
This regulatory science tool (RST) is a laboratory method for measuring the spatial resolution of optical see through augmented reality head mounted displays (AR HMDs) using point spread function analysis.
This regulatory science tool (RST) is a laboratory method that calculates the Contrast Transfer Function (CTF) of Augmented Reality (AR) and Virtual Reality (VR) head mounted displays (HMDs) by quantifying the Michelson contrast as a function of spatial frequency for horizontal or vertical grille patterns displayed on the HMD.
Registration-based Automated Matching and Correspondence (RAMAC) is a tool that automatically identifies corresponding locations of landmarks across multiple images.
This regulatory science tool (RST) is a lab method that is intended to assist in the detection and quantification of volatiles in aqueous extracts using dynamic headspace gas chromatography-mass spectrometry.
This regulatory science tool is a lab method to measure flow resistivity in microfluidic-based devices, which may be used to identify flow-related failure modes (e.g., bubbles, leakage).
This regulatory science tool is an AI model tool used for developing and evaluating deep learning-based survival models.