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Regulatory Science Tools Catalog

Materials Program Image
This tool provides protocols for conducting preclinical tests recommended in the FDA Guidance for tissue containment systems used during power morcellation procedures.
Orthopaedics
Recommended best practices for executing in vitro human cadaver fatigue loading and multidirectional flexibility assessment of lumbar integrated fixation device constructs.
MID
Best practices for standardized performance testing of infrared thermographs intended for fever screening
Materials Program Image
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
A method to estimate device-specific noise from ECG records for algorithm testing
Materials Program Image
A tool to determine the extractables profile of additive-manufactured orthopedic casts produced by fused filament fabrication method
MID
A mathematically easy to understand and experimentally simple method to quantitatively and objectively evaluate endoscope geometric distortion
Neurology
Non-clinical biomarkers of brain injury derived from epidermal and epidural electroencephalographs
Cardiovascualar
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
A simple and compliant fluid reservoir appropriate for in-vitro blood trauma testing.
Cardiovascualar
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