Introduction to US FDA Medical Device Regulatory Process

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.

Want more information about the regulatory process in the USA? Watch this more detailed video: Overview of the USA regulatory framework for medical devices.
Runtime: 24 minutes.

FDA Regulatory Strategy
FDA Device Classification
US FDA 510(k) Preparation
UDI Compliance Consulting
FDA QSR Implementation
US Agent Representation