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Renew Your FDA Initial Importer Designation with Provision
The FDA renewal period for medical device establishments runs October 1 – December 31, 2026. This includes your U.S. Initial Importer.
FDA fee for FY2027: $13,785 per establishment
Initial importers must register and pay FDA’s annual establishment registration fee, just like manufacturers. By designating Provision as your Initial Importer, you avoid setting up and paying for your own initial importer registration.
Why does this matter?
Every foreign-made medical device sold in the U.S. must be tied to an FDA-registered Initial Importer. If that registration is not renewed, the device’s link to a valid importer is lost.
What happens if the renewal is missed?
Your shipments can be delayed or detained at customs.
The importer’s registration lapses, and a new one must be filed.
Your devices may be left without a valid Initial Importer on file when you need it most.
Why stay with Provision as your Initial Importer?
A real U.S. presence. FDA requires a staffed U.S. address responsible for compliance. We provide it.
Post-market duties handled. Adverse event reporting, corrections and removals, complaints, recalls, and inspection support.
U.S. Agent service. We are your contact for FDA inspection notices, warning letters, and import alerts.
Customs support. We help with clearance tied to initial importer identification.
One partner. You focus on making devices, and we handle the U.S. regulatory side.
Renew with us.
To keep your designation active for the coming year, please contact us before the deadline. We’ll take care of the rest.
Contact Us to renew your Initial Importer service.
For inquiries or expert assistance, please contact us today.
CONTACT US
Office: 1-909-493-3276
Email: ask@provisionfda.com