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 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 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 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.
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
Tools that quantify wait-time-saving benefits for cases with positive diagnoses due to the adoption of Computer-Aided Triage and Notification devices in a radiology workflow
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.
An improved and faster method for viral challenge testing of PPE materials
A statistical approach for estimating the likelihood of wireless coexistence of a medical device in its intended environment based on experimental evaluation and realistic environment measurements
A method to assess texture reproduction of camera-phone-based medical devices with a dead leaves target
This tool provides protocols for conducting preclinical tests recommended in the FDA Guidance for tissue containment systems used during power morcellation procedures.
Lumbar Integrated Fixation Devices-Best Practices for Biomechanical Evaluation Under Fatigue Loading
Recommended best practices for executing in vitro human cadaver fatigue loading and multidirectional flexibility assessment of lumbar integrated fixation device constructs.
Tool for assessing image quality of advanced nonlinear CT image reconstruction and denoising products, including but not limited to statistical iterative, model-based iterative, and deep learning-based methods
Best practices for standardized performance testing of infrared thermographs intended for fever screening
A Method Using 3D Printed Surrogate G-Tubes and Newtonian Analog Fluids to Compare the Flow Rates with Commercial Diets in G-Tubes with the New ISO 80369-3 Connector
A tool to determine the extractables profile of additive-manufactured orthopedic casts produced by fused filament fabrication method
A mathematically easy to understand and experimentally simple method to quantitatively and objectively evaluate endoscope geometric distortion