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Export-Only Devices

Exporting devices not cleared/approved in the USA​

Under FD&C Act § 801(e), a device that is not cleared or approved for the US market may still be exported if it:

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

Certificates for Foreign Government (CFG)​

FDA issues Certificates for Foreign Government (CFG) — also known as "export certificates" — upon request. These certificates attest to:

  • The device's regulatory status in the USA (cleared/approved, or not in violation of the FD&C Act for export purposes)
  • The establishment's registration status
  • GMP compliance

Certificate to Foreign Government (for uncleared/unapproved devices — § 802)​

For devices not cleared/approved in the USA, FDA may issue a § 802 certificate if the device meets certain conditions, including that it is manufactured in accordance with 21 CFR Part 820 (QMSR) and is not adulterated or misbranded.

Official resources​