Checking Eligibility and Requirements
Before renewing an FDA registration, businesses must confirm that their facility is still active and eligible for renewal. The FDA requires all domestic and foreign food, drug, and medical device facilities to renew registration every two years. This process ensures that accurate and current details are maintained in the FDA database. Companies should review all operational information, how to renew FDA registration such as business addresses, contact persons, and product types, to verify accuracy before submission. Missing or outdated information can delay approval or result in cancellation.
Accessing the FDA FURLS Account
Renewal is done through the FDA Industry Systems (FURLS) platform. The account owner or designated official must log in and access the registration module. Once inside, the user can choose the renewal option and update necessary details. It is important to ensure that the U.S. agent information for foreign facilities is current, as this representative is vital for FDA communication. Payment of the required renewal fee, if applicable, should be made promptly to avoid delays. Keeping a copy of the confirmation page and acknowledgment email serves as proof of completion.
Ensuring Post Renewal Accuracy
After submitting the renewal, businesses should verify that their registration status shows as “active” in the FDA database. This confirms that the renewal was processed successfully. Any subsequent operational or ownership changes must be promptly updated to maintain compliance. The FDA may conduct inspections or audits to validate information, so maintaining accurate records is essential. Facilities failing to renew risk cancellation, which can lead to import holds or restricted distribution within the U.S. Staying proactive with FDA registration renewal ensures smooth regulatory operations and uninterrupted product movement.