Devices

CDRH Moving to Electronic Export Docs

CDRH says it is transitioning from paper export documents for medical devices to electronic export documents starting 1/2/2024. The documents that will 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.

A 7/10 letter to device makers says that all certificate requests received by 12/15 will be issued as paper certificates. Any requests received after this date will be issued as paper certificates if the review is completed prior to 1/2/2024.

The letter also says that the electronic export documents will be issued 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,” it says. “The FECV will be accessed using the URL address or QR code displayed at the bottom of each certificate.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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