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The FDA’s Registration Process for Devices

Learn the basics of registering a medical device within the United States

Since 2007, the FDA has mandated that all companies that manufacture, import and/or distribute medical devices in the United States must register their facilities accordingly.

In this simple guide, we provide an overview of the registration process along with some important points to consider such as fees and annual renewal details.

What you'll find inside:

• The requirements for registering medical device manufacturing facilities with the FDA
• How to follow medical device registration process
• The differences between initial and annual registration requirements