FDA Updates to the Catalog of Regulatory Science Tools to Help Assess New Medical Devices

The U.S. Food and Drug Administration (FDA) updated its Catalog of Regulatory Science Tools by adding four new tools and updating nine.

The Catalog of Regulatory Science Tools is a peer-reviewed resource with over 120 tools, including phantoms and lab methods that medical device developers can use to help assess new medical technologies. The tools reduce the need for device developers to design ad hoc test methods and allow them to focus their limited resources on assessing how well their new product works, not how to perform the assessment.

The new tools are:

• 2D Human Induced Pluripotent Stem Cell-derived Cardiomyocyte Cardiac Contractility Modulation Tool: 2D hiPSC-CM CCM Tool
• Extractables Screening Protocols for Fused Filament Fabricated ABS Containing Additive-manufactured Devices
• Cardiac Action Potential Model of the Dog
• Identifiability of Cardiac Electrophysiology Models

The updated tools are:

• The Virtual Family: A Set of Anatomically Correct Whole-body Computational Models
• MIDA: A Multimodal Imaging-Based Model of the Human Head and Neck
• ECG Noise Extraction Tool (ECGNExT)
• Electrophysiological Biomarkers for Non-clinical Safety Evaluation of Neuro-interventional Devices
• MCGPU: GPU-accelerated Monte Carlo X-ray Imaging Simulator
• Parsimonius Cardiac Action Potential Model of the Rabbit
• Method for Assessing Texture Reproduction of Camera-phone-based Medical Devices
• Performance Test Methods for Evaluation of Fluorescence Imaging Systems
• Digital Models of Retinal Vasculature for 3D Printed Phantoms

Questions?

For more information please email us at: [email protected] and ref: Catalog of Regulatory Science Tools.

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