Electronic Export Documents – Letter to Industry

July 10, 2023

Dear Medical Device Manufacturer:

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) will be transitioning from paper export documents for medical devices to electronic export documents starting January 2, 2024. Documents to be issued electronically include:

Certificate to Foreign Government,
Certificate of Exportability Section 801(e)(1) or 802,
Non-Clinical Research Use Only Certificate,
Certificate to Foreign Government for Device Not Exported from the United States, and
Export Permit Letter.

All certificate requests received by December 15, 2023, will be issued as paper certificates.

Requests received after December 16, 2023, will be issued as paper certificates if the review is completed prior to January 2, 2024.

All requests received after January 2, 2024, will be issued electronically.

Export documents for human medical device products that CDRH regulates will be issued electronically as downloadable PDFs through the CDRH Export Certification Application and Tracking System (CECATS). Certificates may be validated by foreign governments and others using the FDA’s FURLS Export Certificate Validator (FECV) database for the time period they are in effect. The FECV will be accessed using the URL address or QR code displayed at the bottom of each certificate. The change from paper to electronic PDF will improve efficiency in issuing export documents, reduce the amount of time it takes for a manufacturer to receive export documents, and decrease environmental burden.

You may request an export document using CECATS. To access CECATS, a requestor must have an FDA unified registration and listing systems (FURLS) account ID and password. If you do not currently have a FURLS account, you may create a new account at any time to gain access to FURLS. With the new electronic process, you will receive an email notification of approval with instructions on how to access the document at which point you can access the export certificate through CECATS. You should print or download the document within 45 days of issuance, as the document will not be available to print or download after this time period. Additionally, applications will no longer include delivery instructions or require you to upload a mailing label.

Starting January 2, 2024, requestors and foreign governments will be able to verify the authenticity of an export certificate through CECATS and the FURLS Export Certificate Validator (FECV) databases. Requestors and foreign governments can reach the FECV site by scanning the unique Quick Response (QR) code on the export document and entering the unique certificate number on the FECV site, enabling faster authentication.

The issuance of an electronic certificate will not result in any changes to the format or content of the certificate.

If you have any questions regarding this procedural change, please email Exportcert@cdrh.fda.gov.

For more information:

Sincerely,
Leila Lawrence
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