September 23, 2026
Foley Viewpoints
FDA Medical Devices: Important Regulatory Considerations for Companies Seeking to Enter the U.S. Market
The medical device market in the U.S. is very large and attractive to many companies who are located outside of the U.S. Entering the U.S. medical device market requires a comprehensive, integrated strategy that goes beyond U.S. Food and Drug Administration (FDA) product clearance or approval — an effective market strategy must address key regulatory, quality, reimbursement, and commercial considerations.