How to Fill Out Form FDA 3613: Certificate to Foreign Government (CFG)

To fill out FDA Form 3613, the Supplementary Information sheet for a Certificate to Foreign Government, you provide three things: identifying information for every manufacturing facility involved, the product’s name and U.S. marketing authorization details, and a signed statement from a responsible official of the exporting firm. The form itself is straightforward; the mistakes that stall requests almost always sit in the marketing status field or the firm identifiers. Most exporters now submit the information through the FDA’s online CECATS system rather than mailing the PDF, and the agency has 20 working days from a complete request to issue the certificate.1Office of the Law Revision Counsel. 21 USC 381 – Imports and Exports

What Form 3613 Covers

Form 3613 supports a request for a Certificate to Foreign Government (CFG), the FDA document that confirms a product is legally marketed in the United States.2U.S. Food and Drug Administration. Description of FDA Forms for Export Certification Foreign regulators and importers often require the CFG as proof of U.S. status before they’ll admit a product.

The form works across FDA centers: medical devices through CDRH, biologics through CBER, drugs through CDER, veterinary products through CVM, and human foods through HFP.3U.S. Food and Drug Administration. Export Certificate Fees One boundary to know before you fill anything out: a CFG is only for products with U.S. marketing authorization. If your product isn’t cleared, approved, or otherwise authorized for U.S. marketing, you need a different certificate type (a Certificate of Exportability under Section 801(e)(1) or 802, or a Non-Clinical Research Use Only Certificate), which you request through the same online system.4U.S. Food and Drug Administration. Types of Export Certificates

What to Gather Before You Start

Have these in front of you before you open the form or log in to CECATS. Missing any one of them is the usual reason a request gets kicked back:

  • The street address of every manufacturing facility involved. P.O. boxes are not accepted.5Food and Drug Administration. FDA Form 3613
  • The FEI (Firm Establishment Identifier) for each facility. If you don’t know it, look it up free through the FDA’s FEI Portal.
  • The firm registration number, tax ID code, and contact details (phone, fax, email).
  • The product’s proper name, trade name, and product code where applicable.
  • The specific marketing authorization number and approval date: BLA/STN, HDE, NADA, ANADA, NDA, PDP, PMA, or 510(k).
  • Confirmation that your establishment registration is current. A lapsed registration will block the certificate no matter how clean the rest of the application is.

Filling In the Manufacturer Section

List each manufacturing firm separately. If the product is made at more than one facility, every facility gets its own entry, and the form provides space for multiple manufacturers.5Food and Drug Administration. FDA Form 3613

For each entry you’ll enter the street address (no P.O. box), FEI number, firm registration number, phone and fax numbers, firm tax ID code, and email address. The FEI is the field to be careful with. FDA systems use it to pull your registration and inspection history, so a wrong or missing number is one of the fastest ways to stall the request.

Filling In the Product Section

For each product on the certificate, enter:5Food and Drug Administration. FDA Form 3613

  • The proper name (the established or common name).
  • The product code, if one applies.
  • The trade name under which it’s sold.
  • The marketing status: the type of authorization (BLA/STN, HDE, NADA, ANADA, NDA, PDP, PMA, or 510(k), including preamendment or exempt), along with the number and approval date.

Marketing status is where most requests go wrong. The FDA issues a CFG only for products legally marketed in the United States, so the specific clearance or approval number has to match the product being exported. A wrong 510(k) number, a blank field, or a number that belongs to a different product line means the agency can’t verify status, and the request will not go through.

Signing the Exporter’s Certification Statement

A responsible official of the exporting firm must sign the Exporter’s Certification Statement and enclose it with the request.2U.S. Food and Drug Administration. Description of FDA Forms for Export Certification The signer attests that the product complies with applicable FDA regulations. The form also requires the printed name, title, and date. An unsigned certification will cause a rejection, and the signer must actually be a responsible official, not simply an available employee.

One boundary if you’re exporting human cells, tissues, and tissue-based products (HCT/Ps): there are two different Exporter’s Certification Statements depending on when the tissue was procured. Products procured before May 25, 2005 use the statement covering 21 CFR Part 1270; products procured on or after that date use the statement covering 21 CFR Part 1271.2U.S. Food and Drug Administration. Description of FDA Forms for Export Certification

How to Submit

The FDA strongly prefers submissions through CECATS, the Certificate Export/Certification Tracking System. If you mail a paper Form 3613, the agency will contact you and ask you to resubmit through CECATS.6U.S. Food and Drug Administration. How to Request Export Certificates or Permits and How to Submit Simple Notifications CECATS validates firm data in real time, catches errors before a reviewer sees them, and lets you track the request as it moves.

To submit:

  • Log in to the FDA Unified Registration and Listing System (FURLS) at access.fda.gov using your establishment’s FURLS account ID and password. If you don’t have a FURLS account, register your establishment first.
  • Open CECATS from within FURLS.
  • When asked whether the devices will be exported from the United States, answer Yes to reach the CECATS home screen.
  • Select Certificate to Foreign Government as the certificate type.
  • Complete the required fields (the same information Form 3613 collects) and upload any supporting documents, such as mailing labels.

Every page in CECATS has a question-mark icon linking to help documentation for that step. Repeat exporters should use the clone feature, which auto-populates fields from a previous application and cuts down on data-entry errors.

CBER-regulated products (biologics, vaccines, blood products) use the same portal at access.fda.gov.5Food and Drug Administration. FDA Form 3613

Fees

Federal law caps the fee at $175 per certificate, and fees are collected only when a certificate is issued within the 20-day statutory window.1Office of the Law Revision Counsel. 21 USC 381 – Imports and Exports The first certificate is $175 across every center. Additional copies in the same request are discounted, and the exact schedule varies by center:3U.S. Food and Drug Administration. Export Certificate Fees

  • CDRH: $175 first, $85 each additional.
  • CBER: $175 first, $175 second, $85 each additional.
  • CDER: $175 first, $90 second (with attachments), $40 each additional.
  • CVM: $175 first, $155 second, $70 each additional.
  • HFP: $175 first, $155 second, $100 each additional.

If you need copies of the same certificate for several importing countries, ordering them together in one request is cheaper than filing separate requests.

Timing and Reasons a Request Gets Denied

By statute, the FDA must issue the certificate within 20 working days of receiving a complete request.1Office of the Law Revision Counsel. 21 USC 381 – Imports and Exports CECATS tends to run faster than paper because it validates firm data at submission and lets you track status in real time.6U.S. Food and Drug Administration. How to Request Export Certificates or Permits and How to Submit Simple Notifications

The FDA will not issue a CFG when:

  • It has initiated an enforcement action against the product or manufacturer, such as a seizure or injunction.
  • The manufacturing facility is not registered or listed with the FDA.
  • The facility is out of compliance with current Good Manufacturing Practice regulations, unless the specific cGMP deficiency doesn’t affect the exported product.
  • The product is not actually being exported from the United States.

If the FDA denies a device request for an establishment registered under Section 360, it must provide a written explanation identifying the specific finding, and where the basis is cGMP noncompliance rather than an injunction, seizure, or Class I/II recall, that written explanation must include a substantive summary of the noncompliance grounds.1Office of the Law Revision Counsel. 21 USC 381 – Imports and Exports Read that letter carefully. It’s your roadmap for fixing the issue and resubmitting.

Once the certificate is issued, keep a copy with your export records. Foreign customs officials and importers commonly ask for it at the point of entry.