FDA to transition to electronic export documents for devices in 2024
Starting next year, the US Food and Drug Administration (FDA) will transition key export documents for medical devices from paper to digital format to reduce paperwork and streamline their workflow.Starting 2 January 2024, export documents for human medical devices that are regulated by the Center for Devices and Radiological Health (CDRH) will be issued electronically by FDA as downloadable PDFs from CDRH’s Export Certification Application and Tracking System (CECATS). The agency says the documents may then be validated by foreign governments and other entities who use the FDA Unified Registration and Listing Systems (FURLS) Export Certificate Validator (FECV) database. Companies can access the FECV online database from a web address or a QR code on the 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,” said FDA.
The list of export documents 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
FDA will still issue paper certificates for all requests received by 15 December 2023, and those received after 16 December will only receive paper certificates if the review is completed before 2 January 2024. After that, all requests will be handled electronically by the agency.
To access the CECATS system, a company must have a FURLS account and password, which they can create at any time. The requester will receive an email confirmation that they’ve been approved to use the system and instructions on how to access their 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,” FDA said. “Additionally, applications will no longer include delivery instructions or require you to upload a mailing label.”
After the export documents are fully handled only electronically, requestors and foreign governments will be able to verify export certificates through the CECATS and FEVC databases. FDA emphasizes that digitizing the documents will not change their format or content.
FDA
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