January 2, 2024
Dear Medical Device Manufacturer:
Today, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) began issuing electronic export documents for medical devices. The change from paper to electronic PDF improves efficiency in issuing export documents, reduces the amount of time it takes for a manufacturer to receive export documents, and decreases environmental burden.
Electronically issued documents include:
- Certificate to Foreign Government (CFG);
- Certificate of Exportability (COE) under section 801(e)(1) or 802 of the Food, Drug, and Cosmetic Act (the FD&C Act);
- Non-Clinical Research Use Only Certificate (NCR);
- Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE); and
- Export Permit Letter.
All export documents issued by CDRH on or after January 2, 2024, will be delivered electronically as downloadable PDFs through the CDRH Export Certification Application and Tracking System (CECATS). With the new electronic process, you will receive an email notification of approval with detailed instructions on how to access the document. One time access will be granted to print or download the document within 45 days of issuance. After 45 days, the document will no longer be available to print or download.
IMPORTANT NOTE: Apostilles and authentications of certificates must be printed in color to be valid.
Additionally, without the need for an account, foreign governments and others can verify the authenticity of an export certificate through the FDA Unified Registration and Listing Systems (FURLS) Export Certificate Validator (FECV) for the time the document is valid. Exports certificates are valid for 2 years from the date issued. Foreign governments and others can reach the FECV by scanning the unique Quick Response (QR) code on the export document and entering the unique certificate number into the FECV, enabling faster authentication.
The issuance of an electronic certificate does not result in any changes to the format or content of the certificate.
If you have any questions regarding electronic export documents for medical devices, please email Exportcert@cdrh.fda.gov.
For more information:
- Exporting Medical Devices
- CECATS Help Docs (Step by step submission and printing instructions)
- How to Request Export Certificates or Permits and How to Submit Simple Notifications
- FDA Export Certification Guidance
- FDA Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996
- The Federal Food Drug and Cosmetic Act (Sections 801 and 802)
Assistant Director for Exports
Division of Regulatory Programs 2 (Establishment Support)
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
U.S. Food and Drug Administration