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 enables assessment of a fundamental optical coherence tomography (OCT) system performance parameter.
This regulatory science tool is a lab method that may be helpful while evaluating Photoacoustic Imaging devices.
This regulatory science tool (RST) is a method to evaluate the photochemical damage potential of products that include an optical imaging system and fluorescent contrast agent.
This tool describes a method for testing medical device electromagnetic immunity to proximity fields emitted by 5G FR1 wireless communication equipment.
This tool provides an accelerated aging test protocol for assessing pulse-induced capacity degradation in primary lithium batteries for Active Implantable Medical Devices (AIMDs).
This Regulatory Science Tool (RST) is a lab method for testing medical device electromagnetic immunity to consumer-grade wireless power transfer (WPT) systems as part of assessing Electromagnetic Compatibility (EMC) of medical devices.
This regulatory science tool is a software tool that computes select controller response metrics relevant to physiologic closed-loop controlled (PCLC) medical devices. The tool accepts response data of a controlled physiologic variable collected from any testing modality, including in vivo animal studies, clinical studies, bench testing, or computational simulation, and calculates a set of closed-loop controller response metrics, including median performance error, median absolute performance error, wobble, percentage of time within target range, rise time, percentage overshoot, settling time, divergence, and steady state error.
This regulatory science tool (RST) is an air monitoring method that uses commercially available monitoring badges to evaluate volatile organic compound (VOC) emissions from newly manufactured neonatal incubators.
This regulatory science tool is a dataset of 100 healthy pediatric cranial computed tomography (CT) images with associated demographic data, intended to serve as a normative reference for developing, validating, and assessing the performance of medical devices, particularly artificial intelligence and machine learning (AI/ML) software, designed for pediatric neuroimaging applications.
This regulatory science tool (RST) is a quantitative optical coherence tomography angiography (qOCTA) method to measure the absolute velocity of individual blood cells within retinal microvasculature and map 3D flow rates.
This regulatory science tool (RST) is computational material model of polyurethane bone foam with a density of 20 pounds per cubic foot (PCF), which can be implemented in a finite element analysis application.
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.