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 scanning light scattering profiler (SLSP) method for quantitative evaluation and nonclinical measurement of light scattering characteristics of both current and new-technology intraocular lens (NTIOL) implants.
This regulatory science tool (RST) is a dual-confocal laser caliper test method for refractive-index and thickness measurement of intraocular lens (IOL) implants and thin films
This regulatory science tool (RST) is a confocal laser method to evaluate the dioptric power of commercially available and new-technology intraocular lens (NTIOL) implants.
This regulatory science tool (RST) is a Test Method to easily and efficiently assess the integrity of an additively manufactured (AM) medical device or component that is intended to seal air.
This regulatory science tool (RST) is a browser-based resource for identifying a target speckle size and suitable patterning approach when planning digital image correlation (DIC) measurement studies of implantable medical devices.
This regulatory science tool (RST) provides a step-by-step protocol to design a 9.5 mm inner diameter recirculating flow loop test system and perform bench-top thrombogenicity testing of catheter-like blood-contacting medical devices and materials. Additionally, this tool describes a dynamic pump occlusion setting method to improve blood flow rate consistency between different roller pumps.
This regulatory science tool is a laboratory method for measuring fit-factor of pediatric facemasks.
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).
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.