Medical Devices FAQs

Overview of Medical Device Regulation

How can I find out if my product is regulated by CDRH?

How to Market a Medical Device

What protocol needs to be followed to get a medical device approved?

What are the steps to prepare and submit a Premarket Notification (510(k)) application?

How can I find out how FDA will classify my device?

Does my device need to be labeled? What information should be included in the labeling?

Importing and Exporting Devices

What must I do to import medical devices and radiation-emitting products into the US?

What must I do to export medical devices and radiation-emitting products from the US?