Medical Devices FAQs Share Tweet Linkedin Email Print 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?