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Today, the U.S. Food and Drug Administration (FDA) updated its Catalog of Regulatory Science Tools by adding 9 new tools and updating 3.
The Catalog of Regulatory Science Tools is a peer-reviewed resource with over 150 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:
- An In Vitro Blood Flow Loop System for Thrombogenicity Evaluation of Medical Devices and Biomaterials
- CHemical RISk calculators (CHRIS) – Bulk Chemicals (v2)
- CHemical RISk calculators (CHRIS) – Color Additives (v2)
- CHemical RISk calculators (CHRIS) – Extraction Efficiency
- LCD-CT: Low-contrast Detectability (LCD) Test for Assessing Advanced Nonlinear CT Image Reconstruction and Denoising Methods
- Mechanical and Leakage Integrity Testing Protocols for Evaluating the Performance of Tissue Containment Systems Used During Power Morcellation Procedures
- Protocols for Characterizing Aerosol Emission from Heater Cooler Devices
- QuCAD: Software to Evaluate Wait-Time-Saving Benefits of CADt Devices
- Toolkit for Evaluation of Head Mounted Display Image Quality
Updated:
- Benchmark Validation Dataset for Laminar Flow in an Anatomical Vascular Model of the Inferior Vena Cava
- iMRMC: Software to do Multi-reader Multi-case Statistical Analysis of Reader Studies
- Method for Fabrication of Microcalcifications for Insertion into Phantoms used to Evaluate X-ray Breast Imaging Systems
Questions?
If you have questions about these tools, please email OSEL_CDRH@fda.hhs.gov.
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