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 is a lab method for performing platelet and leukocyte count assays per the <a href="https://www.iso.org/standard/63448.html">ASTM F2888-19 standard</a>, as a part of in vitro thrombogenicity assessment of blood-contacting medical device materials.
This regulatory science tool comprises a computer model of a human action potential, which includes the effects of heart failure (HF) and the anti-arrhythmic drugs amiodarone (AM) and d-sotalol (DS).
This regulatory science tool is a lab method tool used for simulating target clinical use patient conditions on the bench using a mock circulatory loop in conjunction with the ISO 14708-5 standard specifications for circulatory support devices.
This regulatory science tool is a lab method in the form of a physical mock circulation loop (MCL) used for simulating peripheral radial pressure waveforms.
This tool provides a benchmark validation data set for laminar flow in an anatomical vascular model of the inferior vena cava (IVC).
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.
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
A tool which may be used for measuring aerosol emission from water-based heater cooler devices with product codes DWC or DWJ.
This study demonstrates the application of gold-standard method of manufactured solutions (MMS) code verification to verify a commercial finite element code for elastostatic solid mechanics analyses relevant to medical devices. The Python/SymPy code used to generate source terms is available as supplemental material.
Parsimonious (reduced complexity) model and software of the rabbit action potential amenable to large scale simulations of arrhythmias
An approach for optimal experimental design and estimability analysis for mechanistic models of cardiac electrophysiology to determine their ‘identifiability’
A method to estimate device-specific noise from ECG records for algorithm testing
A simple and compliant fluid reservoir appropriate for in-vitro blood trauma testing.
An implementation of a canine action potential model appropriate for comprehensive parameter sensitivity analysis and uncertainty quantification
A tool to assist with evaluating and quantifying contractile response of non-excitatory electrical stimulation signals including CCM in vitro using 2D human cardiomyocyte models
A "threshold-based" validation approach that provides a well-defined acceptance criterion, which is a function of how close the simulation and experimental results are to the safety threshold, for establishing the model validity.
This tool provides a step-by-step protocol to design a recirculating flow loop test system and perform in vitro thrombogenicity testing of catheter-like blood-contacting medical devices and materials using blood from several animal species. The protocol also provides details about different markers for thrombogenicity testing.