US FDA to move to electronic medical device export documents

Background:

As of January 2, 2024, 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, as per a recent letter communicated to the industry on July 10.

The Documents to be issued electronically include:

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

Implementation timelines:

1. All certificate requests received by December 15, 2023, will be issued as paper certificates.
2. Requests received after December 16, 2023, will be issued as paper certificates if the review is completed prior to January 2, 2024.
3. All requests received after January 2, 2024, will be issued electronically.

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