PMA | PMA Import | Export | CFG | CFS | Regulatory Doctor

Certificates for Foreign Government

While FDA does not place any restrictions on the export of these devices, certain countries may require written certification that a firm or its devices are in compliance with U.S. law. In such instances FDA will accommodate U.S. firms by providing a Certificates for Foreign Government (CFG). These export certifications were formerly referred to as Certificates for Products for Export or Certificates of Free Sale. The CFG is a self certification process that is used to speed the processing of requests. To obtain instructions on how to obtain a CFG, call 301-796-7400. (exportcert@cdrh.fda.gov) If you are unable to reach a person on the Export Certificate Team, please call 301-796-7400.

via Premarket Approval (PMA) > PMA Import/Export.

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