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Introduction to US FDA Medical Device Regulatory Process

The United States is the number one medical device market in the world. This 4 minute video explains the medical device registration process in the USA, and the process for gaining approval from the FDA.

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The United States is the number one medical device market in the world, accounting for more than 40% of all healthcare spending worldwide. The US has 310 million people and the highest per-capita spending on healthcare worldwide. Interested in learning more about the process to gain clearance and sell your products in the USA? This short video tells you how. Topics covered include the FDA, the CDRH (the division which regulates medical devices), how to determine the classification of products in the USA, Good Manufacturing Practice (GMP), inspections, 510(k) and PMA submissions, and more.