Establishments involved in the production or distribution of medical devices intended for use in the United States must register with the U.S. Food and Drug Administration (FDA). Establishments located outside of the United States must also designate a U.S. Agent for FDA communications.
The registration is a two-step process, first, the fee must be paid to FDA then the registration can occur. The time frame between the payment and final registration is typically one week. Once a medical device registration has been completed the contact email address will receive a confirmation email.
Facility Registration and Device Listing includes a Certificate of Facility Registration and Device Listing for the first 3 products