Regulatory Science Tools Catalog
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
A tool which may be used for measuring aerosol emission from water-based heater cooler devices with product codes DWC or DWJ.
Test methods that provide a practical approach for objective, quantitative evaluation/comparison of fundamental performance in near-infrared fluorescence imagers.
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
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
Best practices for standardized performance testing of infrared thermographs intended for fever screening
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
Non-clinical biomarkers of brain injury derived from epidermal and epidural electroencephalographs
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.
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
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.