Importance of Renewing FDA Registration
Renewing FDA registration is a vital process for businesses involved in manufacturing, processing, or distributing food, drugs, or medical devices within or outside the United States. The renewal ensures that a company maintains compliance with federal regulations and continues to have legal authorization to operate. Every two years, the U.S. Food and Drug Administration requires facilities to renew their registration to keep the database current and accurate. Missing the renewal deadline can result in serious consequences, including removal from the FDA registry or restriction from importing and exporting products.
Steps to Renew FDA Registration Successfully
To renew FDA registration, companies must review and verify all existing details about their facility, products, and operations. The process usually involves logging into the FDA Industry Systems portal, updating information if necessary, and submitting the renewal request during the designated period—typically between October 1 and December 31 of even-numbered years. Appointing a reliable U.S. agent is also mandatory for foreign facilities. Having accurate documentation, such as the facility registration number and device listing (if applicable), ensures a smooth and efficient renewal process without delays or rejections.
Common Mistakes and How to Avoid Them
Many businesses fail to renew their FDA registration on time due to lack of awareness or incomplete submissions. Common errors include providing outdated contact details, skipping the verification step, or missing the renewal window. To avoid such issues, companies should set reminders well in advance, keep all records updated, and work with professional FDA compliance consultants when necessary. Maintaining consistent communication with the U.S. agent also helps prevent missed notifications or technical errors during submission. Staying proactive and organized guarantees continued FDA compliance and uninterrupted business operations.