Medical Device Regulations / FDA Approval

FDA Approved - What Does That Mean For Medical Devices?

Understanding the FDA Medical Device 510k Process

Understanding the Difference Between FDA Approval and FDA Clearance

How is My Medical Device Classified?

Is My Product A Medical Device

FDA Review and Approval of Drugs and Medical Devices

What Does it Mean to be a Class II Medical Device?

What the FDA’s Proposed Rule to Regulate Lab-Developed Tests Means for Hospitals and Health Systems

FDA Process for Medical Device Startups: an Investor's Point of View

FDA Regulation of Medical Devices and Software/Apps

Medical Devices 101: An Entry Level Overview of the FDA

FDA 101 for Medical Devices

Overview of the USA FDA Classification Process

What is FDA Approval?

Medical Devices: Overview of US FDA regulatory process

FDA Medical Device Regulation by Dr. Emily Zeitler (Dartmouth)

Risk Basics for Medical Devices

FDA Regulation of Medical Devices - Abridged and Simplified

A Roadmap for Medical Devices: From Innovative Ideas to the U.S. Market