What is an FDA export certificate?

An FDA export certificate is an official document issued by FDA under Section 801(e) of the FD&C Act that certifies a U.S. product's regulatory status to a foreign government. These certificates help U.S. manufacturers meet importing country requirements by confirming that products are legally marketed in the U.S. and that the manufacturing facility meets applicable FDA requirements. Many countries require export certificates as a condition of import or product registration.

What types of FDA export certificates are available?

FDA issues several types of export certificates: Certificate of Free Sale (CFS) certifies that the product is legally marketed in the U.S.; Certificate to Foreign Government (CFG) certifies the facility's compliance status and product details; and Certificate of Pharmaceutical Product (CPP) follows the WHO format and certifies drug product marketing authorization and GMP compliance. The correct certificate type depends on your product category and the requirements of the importing country.

Which products are eligible for FDA export certificates?

FDA issues export certificates for products it regulates: foods, dietary supplements, drugs (prescription and OTC), biologics, medical devices, cosmetics, and tobacco products. The product must be manufactured or processed in the U.S. (or in some cases, pass through a U.S. facility). The requesting firm must have a valid FDA registration and, for drugs and devices, current listing information in FDA databases.

How long does it take FDA to process an export certificate?

FDA processing times vary by certificate type and product category. Food and cosmetic certificates typically take 2-4 weeks. Drug and device certificates may take 4-8 weeks or longer, depending on complexity and FDA workload. Expedited processing is available in certain circumstances for an additional FDA fee. Assurentry tracks all applications and provides status updates throughout the process.

Do I need an apostille or legalization for my export certificate?

Many countries require additional authentication beyond the FDA certificate itself. Countries that are parties to the Hague Apostille Convention accept an apostille from the U.S. Department of State. Non-Hague countries may require embassy or consular legalization. Some countries require both. Assurentry advises on destination-country requirements and can coordinate apostille and legalization services.

How much does an FDA export certificate cost?

FDA charges a per-certificate fee (currently $175 for most certificate types, subject to change). Assurentry charges $299 per certificate for the complete application service, which includes certificate type determination, application preparation and submission, processing tracking, and delivery. The FDA fee is paid separately directly to FDA. Volume pricing is available for companies requiring multiple certificates.

Can I get an export certificate for a product not yet FDA-registered?

No. FDA export certificates are based on the product's current U.S. regulatory status. The facility must have an active FDA registration, and for drugs and devices, the product must have current listing information with FDA. For food products, the facility must have current food facility registration. Assurentry can help you complete registration and listing as a prerequisite to obtaining the export certificate.

What if the destination country requires a certificate format FDA doesn't issue?

Some countries require certificates in formats or with language that FDA does not provide. In these cases, Assurentry can help identify alternative documentation strategies, such as combining an FDA certificate with a manufacturer's self-declaration, obtaining certification from a recognized third-party body, or working with the importing country's regulatory authority to determine acceptable documentation. We advise on country-specific solutions based on current trade requirements.

Export Certificate • Official FDA Process

FDA Export
Certificate

U.S. FDA export certificates for food, drug, device, and cosmetic manufacturers demonstrating compliance for international trade.

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Product & Destination Review

We review your product category, FDA registration status, and destination country requirements to determine the correct certificate type.

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We prepare the export certificate application with all required product, facility, and regulatory data and submit through FDA's online portal.

FDA Processing & Tracking

We monitor FDA processing status, respond to any FDA queries, and keep you informed of estimated delivery timelines.

Certificate Delivery & Authentication

We deliver the issued certificate and provide guidance on any additional authentication (apostille, legalization) required by the destination country.