What Is FDA Registration? Why It Is Required for Exporting to the US

What Is FDA Registration?

The FDA (Food and Drug Administration) is the federal agency that regulates food safety, drugs, medical devices, cosmetics and many other product categories in the United States. FDA registration is the requirement that foreign facilities wishing to export these products to the US register with the FDA.

Who Has to Register with the FDA?

All foreign facilities exporting the following products to the US must register with the FDA:

• Food and beverage manufacturers
• Dietary supplement companies
• Cosmetics manufacturers
• Medical device manufacturers
• Food packaging material manufacturers
• Drug manufacturers

What Happens Without FDA Registration?

Products from unregistered facilities face serious enforcement action:

• Detention at the border: Products are held at US customs and denied entry
• Return shipment: Products are sent back to the country of origin
• Destruction: In some cases, products may be destroyed
• Blacklisting: The company and facility may be placed on an FDA blacklist
• Blocking of future shipments: All shipments from the same facility may be blocked

Types of FDA Registration

1. Food Facility Registration

Required for facilities that manufacture, process, pack or hold food, beverages or dietary supplements. The registration must be renewed every even-numbered year (between October and December).

2. Medical Device Establishment Registration

Required for establishments that manufacture, import or distribute medical devices. It must be renewed every year between October 1 and December 31.

3. Drug Establishment Registration

Required for establishments that manufacture or repackage drugs.

The US Agent Requirement

The FDA requires every registered facility located outside the US to designate a US Agent. The US Agent serves as the official communication link between the FDA and the facility and must be reachable 24/7.

Cost of Registration

The FDA does not charge a fee for food facility registration (FDA: food facility registration fees). Medical device establishment registration, however, carries a separate annual FDA user fee (FDA: MDUFA); this fee is not included in the consulting fee. For our current consulting fees, see the US services and fees table.

Conclusion

FDA registration is a critical step that cannot be skipped when entering the US market. Attempting to export without registration can lead to serious financial losses and reputational damage. With professional support, you can complete your FDA compliance process without setbacks.