We know complying with the Federal Codes is a daunting task in itself. Hope they have some word savvy wizards to get them through this.
The most troubling aspect of their enforcement letter was the threat to stop shipments overseas from the US.
"Also, should FDA determine that your devices do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted. More information on processes for persons denied a CFG can be found at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-request-review-fdas-decision-not-issue-certain-export-certificates-devices."
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