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 open-access longitudinal dataset contains raw inertial measurement unit (IMU) and sensorized insole data from individuals with Parkinson’s Disease (PD) synchronized to a gait walkway reference system over multiple time points. This dataset can also be used to examine associations between gait measures, PD severity indicators, and PD progression within the study cohort.
The Respirator Filtration Efficiency Calculator is a conservative computational tool that assists stakeholders with the assessment of personal protective equipment (PPE) textile materials, namely respirator / mask materials, to estimate particle filtration efficiencies compared with those of a reference surgical N95® respirator.
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) provides an applied credibility assessment plan for a computational model-based, patient-specific surgical planning workflow that predicts optimal patch shape in branch pulmonary artery reconstruction.
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) is a series of quasi-static isotropic material models for additively manufactured (AM) Titanium – 6 Aluminum – 4 Vanadium (Ti-6Al-4V) for use in finite element or other engineering analysis techniques.
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 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.