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Update to FDA Certificates

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.


Certificates to Foreign Government (FDA Free Sale Certificates) will be included in this change.


All certificate requests received by December 1, 2023, will be issued as paper certificates. Requests received after December 1, 2023, may be issued as paper certificates or electronic certificates. Requests received in 2024 will be issued electronic certificates.


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


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.



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