FDA Registration - What it Means & What It Doesn't

No items found.
Guidelines & Standards
FDA Clearance
FDA Registered is one of 5 statuses used by the FDA and each of them have their own meanings and uses. Knowing the difference puts you at an advantage in figuring out your products best path to market!

Watch Joel Reid, a Regulatory Affairs Specialist Proxima Clinical Research, review what exactly FDA Registration entails!

Can't watch right now and rather read a quick summary? Here is a recap of what Joel shares in the video:

Hello. Joel here from the team at Proxima CRO.

In this video, we'll be discussing what it means to register and list your product, why it's important, and what sets it apart from other FDA statuses. In order for a medical product to be sold in the United States, all entities involved in the production and distribution of the product are required to register annually with the FDA.

This is known as establishment registration and is to ensure that the FDA is aware of your company and its involvement with medical devices. Most establishments that are required to register are also required to list the devices in a process known as listing so that they may legally be marketed and sold in the United States. This applies to all classes of medical devices.

The registration and listing processes are done electronically and must be completed every fiscal year. The information is uploaded to publicly accessible databases and is key to FDA's efforts to monitor and regulate new devices so that they may be safely marketed and used in the United States. It's important to note that having your device listed with the FDA does not mean that you can claim it's FDA cleared, approved or granted.

Nor can you use the FDA logo on your device's labeling or in manufacturing. These statuses and actions have separate meanings and prerequisites, which we will cover at another time. At Proxima CRO. Our regulatory experts are here to help answer any questions you may have about medical device registration. Please visit our website at to learn more.