FDA Establishment Registration and Listing for Medical Devices

Do you need help with completing your initial FDA establishment registration and listing for a medical device? Watch our video to learn how.

The two most common situations for when a company needs to register their establishment with the FDA is 1) when the company is a contract manufacturer and producing a finished device for the first time, and 2) when the company is a specifications developer that recently received a 510(k) and is about to begin distribution of the newly cleared product. If your company is a specification developer, and you have not yet submitted your first 510(k), then you need to complete your Medical Device User Fee Cover Sheet first. If you have already received 510(k) clearance, or your device is exempt from 510(k) clearance, this article and the associated video will help you complete your FDA establishment registration and listing.

In this video we walk you through the process for accessing the two websites and we identify the most common pitfalls. If you would like to hire us to help you complete the FDA establishment registration process, please use the following calendly link: https://calendly.com/13485cert/regist...

You might also be interested in our blog on this topic:
https://medicaldeviceacademy.com/fda-...