U.S. Food and Drug Administration

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 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 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 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 tool provides an accelerated aging test protocol for assessing pulse-induced capacity degradation in primary lithium batteries for Active Implantable Medical Devices (AIMDs).

This tool describes a method for testing medical device electromagnetic immunity to proximity fields emitted by 5G FR1 wireless communication equipment.

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 regulatory science tool is a lab method that may be helpful while evaluating Photoacoustic Imaging devices.

This regulatory science tool (RST) is a phantom that enables assessment of a fundamental optical coherence tomography (OCT) system performance parameter.

This tool is a how-to guide which demonstrates the design and manufacture of transparent cardiovascular anatomical models with optical access for visualization and measurement of fluid flow (ex. blood flow) using additive manufacturing techniques (3D printing).