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 presents Python-based software for evaluating computer models that predict the number of COVID-19 deaths or hospitalizations expected in a specific locality.
This regulatory science tool presents an open-access dataset tool for the assessment of wearable technology deriving gait parameters.
This regulatory science tool presents a set of tissue-mimicking phantoms suitable for benchtop performance assessment of photoacoustic imaging (PAI) devices.
This regulatory science tool presents a method for assessing credibility of patient-specific computational models implemented in medical device software.
This regulatory science tool is a method that applies the ISO 10993-17 toxicological risk assessment approach to medical device extractables screening data to assess systemic toxicity, genotoxicity, carcinogenicity, or reproductive/developmental toxicity in the biocompatibility evaluation of a medical device.
Chemicals List for Analytical Performance (CLAP)
This tool provides a benchmark validation data set for laminar flow in an anatomical vascular model of the inferior vena cava (IVC).
This RST contains a set of machine or deep learning algorithms which can be utilized in the development of relevant medical devices to assist in the prediction of traumatic brain injury (TBI) and stroke according to resting electroencephalography (EEG).
The 3D human induced pluripotent stem cell-derived cardiomyocyte (hiPSC-CM) Cardiac Contractility Modulation (CCM) Tool, 3D hiPSC-CM CCM Tool, is a laboratory method that includes detailed characterization and protocols for evaluating contractile response in healthy 3D hiPSC-CM models. The core elements of this tool include the ability to perform in vitro CCM contractility assays, including contraction force and kinetics, in 3D hiPSC models for various known and unknown electrophysiology pulse waveform parameters and combinations.
This RST is a database tool consisting of nine mock circulation loop (MCL)-generated datasets for characterizing three dynamic attributes of pressure-based cardiac output monitoring systems that apply an algorithm to intra-radial arterial blood pressure waveforms for cardiac output and stroke volume variation measurements.
This RST, a “threshold-based” validation method, provides a means to determine an acceptance criterion for computational models. A “credible” computational model has the potential to provide a meaningful evaluation of safety in medical-device submissions [1,2].
This RST outlines a strategy for estimating the presence of cyclic phase transformation to aid in the determination of appropriate load levels for Fatigue to Fracture testing of nitinol components. Specifically, it includes a flowchart (Figure 1 in Appendix) to estimate the low to high cycle fatigue transition using either computational or experimental methods. Based on the output of the analysis, the user can create a test plan for fatigue testing per ASTM F3211 which includes both expected low cycle fatigue fractures and runouts.
The DAMSEL tool is a digital collection of published information related to the safety profile of materials commonly used in the manufacture of medical devices. This interactive application allows users to filter and access key response data for studies relating to material biocompatibility along with hyperlinks to the relevant original studies.
The Virtual Imaging Clinical Trials for Regulatory Evaluation (VICTRE) computer modeling pipeline is a set of tools that allow for the replication of clinical trials of in silico breast radiographic images for the evaluation of digital mammography (DM) and digital breast tomosynthesis (DBT) devices.
A performance-based method requiring controlled grasping, transport, and release of objects that can be used to evaluate upper limb functional ability.
The Virtual Family provides detailed three-dimensional computational models of the human anatomy including an adult male, an adult female, and two children
This tool allows for the creation of immersive 3D scenes using a web browser. WebXR allows for an instant deployment of any 3D scene and scripts and does not need to cater to a specific 3D engine or headset hardware
A series of benchmark problems with known exact solutions that can be used to verify if tissue-level (e.g., ventricular, atrial) computational models of cardiac electrophysiology have been implemented correctly
Test methods that provide a practical approach for objective, quantitative evaluation/comparison of fundamental performance in near-infrared fluorescence imagers.
A tool which may be used for measuring aerosol emission from water-based heater cooler devices with product codes DWC or DWJ.