Medical Devices Insights

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Doctor Patient Talking using Tablet

The Basics of the Individual Expanded Access Request Process: A Resource for Physicians

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Application Design

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What are the IRB review requirements for human factors/usability testing?

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Doctor talking to Nurse about an X-ray

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Can a physician submit a single humanitarian use device (HUD) submission to the IRB?

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Nurse holding medical equipment

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Does the Common Rule apply to Medicare-covered investigational device studies?

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microscope

Under the Microscope: Biomarker and Diagnostic Tests as FDA-Regulated Devices

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