Devices

Device Regulatory Science Tool Catalog Update

FDA has updated its Catalog of Regulatory Science Tools to Help Assess New Medical Devices by adding three new tools and updating five tools. An online post says the new tools are:

Additively Manufactured Mock Spine Cage Designs for Mechanical Performance Test Assessments: STL Set 1;
Lumbar Integrated Fixation Devices — Best Practices for Biomechanical Evaluation Under Fatigue Loading; and
VICTRE: In Silico Breast Imaging Pipeline.

The updated tools are:

Endoscope Geometric Distortion — A Method for Quantitative Evaluation;
Infrared Thermographs — Methods for Evaluating Laboratory Performance;
Method for Estimating the Likelihood of Wireless Coexistence;
Modified Dot-Blot Method to Evaluate Personal Protective Equipment; and
Verification Test Problems for Cardiac Electrophysiology Modeling Software.

The post says the catalog provides a peer-reviewed resource for medical device companies to use when standards and qualified Medical Device Development Tools do not yet exist.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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