FDA Implements Certification for Devices Not Exported from the United States
The U.S. Food and Drug Administration (FDA), based upon statutory revisions as a result of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, is implementing a certification for medical devices not exported from the United States. If certain requirements are met, a Certificate for Device Not Exported from the United States (CDNE) may be issued upon request.
In addition, the FDA has revised the web-based application system, CDRH Export Certification Application and Tracking System (CECATS), which can be used for submitting requests for a CDNE. This system offers several benefits, including:
- Reduction in certificate processing time
- Real-time validation of firm-specific data
- Status updates of requests
The FDA updated the final guidance, Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices to include reference to the CDNE process.
Questions?
If you have questions about exporting medical devices, contact cdrhcecats@fda.hhs.gov or call 301-796-7400 Option 3.
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