Regulatory Science Tools Catalog
![AI ML](/sites/default/files/styles/card_large_image/public/2024-01/AI-ML.jpg?h=16255f10&itok=Mm7ieYLf)
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
![Infection Control](/sites/default/files/styles/card_large_image/public/2024-01/Infection%20Control.jpeg?h=3f7bda2c&itok=reY-q1Cn)
A tool which may be used for measuring aerosol emission from water-based heater cooler devices with product codes DWC or DWJ.
![MID](/sites/default/files/styles/card_large_image/public/2024-01/MID.jpg?h=4f4ef907&itok=creHJZ75)
Test methods that provide a practical approach for objective, quantitative evaluation/comparison of fundamental performance in near-infrared fluorescence imagers.
![Infection Control](/sites/default/files/styles/card_large_image/public/2024-01/Infection%20Control.jpeg?h=3f7bda2c&itok=reY-q1Cn)
An improved and faster method for viral challenge testing of PPE materials
![EES](/sites/default/files/styles/card_large_image/public/2024-01/EES.png?h=e0e227b8&itok=CZpaZcNL)
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
![MID](/sites/default/files/styles/card_large_image/public/2024-01/MID.jpg?h=4f4ef907&itok=creHJZ75)
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
![MID](/sites/default/files/styles/card_large_image/public/2024-01/MID.jpg?h=4f4ef907&itok=creHJZ75)
A method to assess texture reproduction of camera-phone-based medical devices with a dead leaves target
![Materials Program Image](/sites/default/files/styles/card_large_image/public/2023-12/Materials4.png?h=de93cae1&itok=DKI6GHTv)
This tool provides protocols for conducting preclinical tests recommended in the FDA Guidance for tissue containment systems used during power morcellation procedures.
![Orthopaedics](/sites/default/files/styles/card_large_image/public/2024-01/Ortho.png?h=b93ac7c1&itok=gfXlA9BQ)
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.
![MID](/sites/default/files/styles/card_large_image/public/2024-01/MID.jpg?h=4f4ef907&itok=creHJZ75)
Best practices for standardized performance testing of infrared thermographs intended for fever screening
![Materials Program Image](/sites/default/files/styles/card_large_image/public/2023-12/Materials4.png?h=de93cae1&itok=DKI6GHTv)
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
![InterOp](/sites/default/files/styles/card_large_image/public/2024-01/Interoperability.jpeg?h=c404ba51&itok=Q6jICSTk)
A method to estimate device-specific noise from ECG records for algorithm testing
![Materials Program Image](/sites/default/files/styles/card_large_image/public/2023-12/Materials4.png?h=de93cae1&itok=DKI6GHTv)
A tool to determine the extractables profile of additive-manufactured orthopedic casts produced by fused filament fabrication method
![MID](/sites/default/files/styles/card_large_image/public/2024-01/MID.jpg?h=4f4ef907&itok=creHJZ75)
A mathematically easy to understand and experimentally simple method to quantitatively and objectively evaluate endoscope geometric distortion
![Neurology](/sites/default/files/styles/card_large_image/public/2024-01/Neuro.jpg?h=43a1839e&itok=gU2A-Yg6)
Non-clinical biomarkers of brain injury derived from epidermal and epidural electroencephalographs
![Cardiovascualar](/sites/default/files/styles/card_large_image/public/2024-01/Cardiovascular2.jpg?h=38fa3d21&itok=TQicflPH)
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.
![Cardiovascualar](/sites/default/files/styles/card_large_image/public/2024-01/Cardiovascular2.jpg?h=38fa3d21&itok=TQicflPH)
A simple and compliant fluid reservoir appropriate for in-vitro blood trauma testing.
![Cardiovascualar](/sites/default/files/styles/card_large_image/public/2024-01/Cardiovascular2.jpg?h=38fa3d21&itok=TQicflPH)
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
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