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 phantom that can be used for the assessment of certain fundamental performance parameters of adaptive optics (AO) imaging systems.
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 lab method for absolute vessel caliber and retinal blood flow velocity measurements in humans using a high-resolution (spatial and temporal) multimodal adaptive optics system with scanning laser ophthalmoscopy (SLO) and optical coherence tomography (OCT).
This regulatory science tool presents a laboratory method to assess the mechanical integrity of anterior vertebral body tethering (AVBT) devices.
The tool provides hemolysis data obtained from inter-laboratory bench experiments within generic and simplified device geometries. Modelers can use the data to perform early-stage evaluation of their computational fluid dynamics (CFD) model of hemolysis.
This regulatory science tool (RST) is a coupon designed for use in tensile testing additively manufactured lattices.
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 benchtop test method for performing material-mediated thrombogenicity assessment of blood-contacting medical devices and materials using molecular biomarkers to characterize platelet and coagulation activation in a single set of tests.
This regulatory science tool (RST) is a phantom that enables image quality assessment of ophthalmic optical coherence tomography (OCT) devices.