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?