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 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 (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 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 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.
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).
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.
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 is a laboratory method for measuring fit-factor of re-used and/or decontaminated N95 respirators using adult manikins.
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.