Have you been wondering how to start planning the regulatory process for your proposed medical device? CDRH offers this web page showing the 5 steps of how to study and market your device, and it’s an ideal first step for the new device sponsor. It shows the 5 steps you must follow before marketing your medical device in the US:

• Step One: Classify Your Device
• Step Two: Choose the Correct Premarket Submission
• Step Three: Prepare the Appropriate Information for your Premarket Submission to the FDA
• Step Four: Send your Premarket Submission to the FDA and Interact with FDA Staff during Review
• Step Five: Complete the Establishment Registration and Device Listing

Each step includes links to further information and databases. I see this as a valuable summary for initial planning and a quick reference page for links to relevant details as you proceed through your marketing application process.

Text Copyright © 2019 Katrina Rogers