Medical Devices Insights

Viewing all entries for: medical devices

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

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

Ask the Experts

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

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

Ask the Experts

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

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

Nurse holding medical equipment

Ask the Experts

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

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

microscope

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

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