2025-2026 Biennial FDA Registration

Starting October 1, 2024, the biennial registration period with the FDA (Food and Drug Administration) for the 2025-2026 period officially opens. This is a crucial time for all businesses that produce, distribute, or import food, medical devices, and drugs intended for the U.S. market. Registration or updating registrations must be completed by no later than December 31, 2024.

FDA Registration Obligations

The FDA requires that all food facilities, both domestic and foreign, renew their registration in even-numbered years. Companies without a valid registration face severe consequences, including the rejection of imported products by the FDA or CBP (U.S. Customs and Border Protection). It is essential for foreign facilities to adhere to these deadlines, as failure to register can lead to the suspension or invalidation of their registration. This means that products from such facilities could be denied entry into the United States.

Additionally, all manufacturers and importers (both domestic and foreign) of medical devices must register their establishments annually. Without a valid registration, facilities risk having their imports detained or rejected.

Consequences of Failing to Register

Failing to meet the registration deadline can have significant repercussions. Companies may face customs holds, non-compliant products could be rejected upon import, and considerable delays in business operations may occur. Moreover, the FDA may implement stricter oversight measures, including additional inspections and tighter compliance demands.

McNeese Customs & Commerce: Your Ideal Partner for FDA Registration

With over 30 years of experience helping Italian businesses comply with FDA regulations, McNeese Customs & Commerce offers a comprehensive range of services to assist with FDA registration, labeling, and the preparation and management of FDA inspections. The goal of our company is to ensure that businesses are fully compliant with U.S. regulations, avoiding delays and potential penalties.

For more information about the services offered by McNeese Customs & Commerce, visit the website or follow our LinkedIn profile.

Don’t let the deadline catch you off guard: contact McNeese Customs & Commerce to navigate the FDA registration process smoothly.