FDA Registration Renewal

Last updated: August 29, 2026

FDA Registration Renewal Deadline 2026

FDA establishment registrations expire on a fixed calendar date rather than on the anniversary of the original filing, so the renewal window is identical for every facility in a given category. The two exceptions are FDA self-identification, which runs May 1 to June 1, and DMF renewal, which falls on the anniversary date of the original submission.

How to Renew FDA Registration — Step by Step

Every FDA renewal follows the same seven steps, but the filing route differs by product type. Drug and medical device establishments file through FDA systems that require a user fee payment or an SPL submission first, while food and cosmetic facilities renew through an FDA Industry Systems account at no FDA fee.

1. Confirm what is actually due. One company often holds several obligations at once — an establishment registration, a product listing, and in some cases an annual self-identification. Renewing the establishment alone leaves the listing out of date and the record incomplete.
2. Recover access to the FDA account first. Renewal requires the account owner credentials, the DUNS number and the official correspondent on file. If the person who created the account has left the company, account recovery has to be requested from FDA before the window closes, and that takes time.
3. Pay the user fee (medical devices). Device establishments must pay the annual establishment registration user fee before the registration can be submitted, then use the Payment Identification Number and Payment Confirmation Number to complete it. There is no small business reduction for this fee. Current amounts are on our FDA fees page.
4. Update the establishment record. Verify the facility address, owner or operator, official correspondent, trade names and, for foreign facilities, the US Agent details. An outdated address is one of the most common reasons a renewal is rejected.
5. Review and update the product listing. Device listings must be reviewed during the renewal window. Drug listings require either an updated listing or a blanket no-change certification — see FDA drug listing renewal. Cosmetic product listings under MoCRA are updated annually.
6. Submit through the correct system. Food and cosmetic facilities submit online through the FDA account. Drug establishments submit SPL files through the FDA Electronic Submissions Gateway. Device establishments complete the renewal in FDA’s device registration and listing module once the fee clears.
7. Keep documented proof of renewal. FDA does not issue a renewal certificate of any kind. LMG issues a free certificate of FDA registration after every renewal we complete, which is what most buyers, customs brokers and marketplaces ask to see.

What Happens If You Miss the FDA Renewal Deadline

An expired registration is treated as no registration at all from January 1 onward. The consequences are commercial as often as they are regulatory:

• FDA may remove the establishment and listing records from its public database.
• Products from an unregistered facility can be considered misbranded under the FD&C Act.
• Shipments may be refused at the port of entry, and a facility can be added to an import alert, which then requires detention and DWPE removal to resolve.
• Distributors, retailers and online marketplaces that verify registration status may suspend open purchase orders.
• A lapsed registration has to be filed again as a new registration, and the original registration number is not always restored.

Late renewal is still better than no renewal, and a lapsed facility can be brought back into compliance. Facilities that want the deadline tracked for them can use the LMG Compliance Monitor, which watches registration status year round.

FDA Registration Renewal Fees

There is no FDA fee to renew a food facility registration, and none to renew a cosmetic facility registration under MoCRA. Medical device establishments must pay an annual establishment registration user fee, which FDA sets for each fiscal year and publishes before the October 1 window opens. Drug establishment registration and drug listing submissions carry no separate filing fee, although generic and OTC monograph facilities owe annual GDUFA or OMUFA facility fees under separate programs. Current figures are listed on our FDA fees page and explained in cost of FDA registration.

FDA Registration Renewal vs FDA Listing Renewal

Registration identifies the facility. Listing identifies the products made or handled there. They are separate obligations with separate records, and a renewal is only complete when both are current:

• FDA drug establishment registration renewal keeps the facility record active for another year.
• FDA drug listing renewal updates the products themselves, or certifies that nothing has changed.
• FDA medical device registration renewal covers the establishment, with the device listing reviewed in the same window.
• MoCRA cosmetic product listing is updated annually even though the facility registration itself renews every two years.

Foreign Facilities and the US Agent Requirement

A US Agent is not required for domestic facilities, but it is mandatory for every foreign facility that registers with FDA. During renewal, FDA verifies the agent by email; if the agent does not confirm, the renewal does not complete, and many lapsed foreign registrations trace back to an agent who stopped responding. Foreign food facilities must confirm the US Agent at every biennial renewal. LMG acts as US FDA Agent for facilities in more than 150 countries and can complete FDA food facility registration renewal within one business day.