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Exporting from USA — CFG & Requirements

Can you export a device not cleared/approved in the USA?​

Yes — under certain conditions. FD&C Act § 801(e) permits the export of devices that are not cleared or approved for the US market if the device:

  1. Meets specifications of the foreign purchaser
  2. Is not in conflict with the laws of the importing country
  3. Is labelled on the outside of the shipping package that it is intended for export only
  4. Is not sold or offered for sale in US domestic commerce

For higher-risk devices, § 802 provides an alternative pathway that requires FDA notification but not approval.

Certificates for Foreign Government (CFG)​

FDA issues Certificates for Foreign Government (CFG) — also known as export certificates — upon manufacturer request. These documents are frequently required by foreign regulators as part of device registration applications.

Types of certificates​

Certificate typeWhat it certifies
Certificate to Foreign Government (CFG)Device's US regulatory status (cleared/approved); establishment GMP compliance
Certificate of Exportability (§ 801(e))Device meets § 801(e) export requirements (for unapproved devices)
GMP certificateFDA-registered establishment complies with QMSR

How to obtain a CFG​

  1. Submit request online through FDA's CFG portal
  2. Pay the applicable fee
  3. FDA issues the certificate (typically within 20 business days)

Key considerations for multi-market manufacturers​

  • Most foreign regulatory authorities require a Certificate of Free Sale (CFS) or CFG as part of their device registration package
  • The CFG confirms FDA registration — it does not substitute for foreign country approval
  • Some countries specifically require that the device be cleared/approved in the USA before they will register it; others accept export certificates for unapproved devices
  • FDA CFGs are not electronic signatures-authenticated — some countries require apostille or notarisation

Official resources​