US FDA Regulatory Process for Medical Devices (video)

This brief video provides a short, high level overview of the US FDA medical device regulatory approval process, and explains the process of complying with FDA regulations for medical devices. Subjects covered:

• How medical devices are classified by the Food and Drug Administration
• 510(k) applications
• FDA registration
• How to use the FDA databases
• Compliance with the FDA Quality System Regulation (21 CFR Part 820) also known as QSR and Good Manufacturing Practice

Other videos you may like, related to medical devices in the United States:

• FDA 510(k): Medical Device Registration Process in the USA
• Steps to Comply with US FDA QSR

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