A CFG can cover a device that never came here.

A device cleared for the US market gets made, start to finish, in a contract facility overseas, and sold only in other countries — it never crosses the US border in either direction. A regulator in the country receiving it still wants paper proving the device’s US status. Until 2022, FDA had nothing it could issue for that device, because its main export certificate was never written to reach a device that does not, in fact, export.

What the CFG has always certified

The Certificate to Foreign Government (CFG) covers a device that “can be legally marketed in the United States” in compliance with the FD&C Act — cleared, approved, De Novo granted, exempt, pre-amendment, or covered by a Humanitarian Device Exemption, with the manufacturing establishment registered and the device listed with FDA. It is a status certificate, read off current registration and listing records, not an independent safety or effectiveness finding, and since January 2024 it is issued electronically as a downloadable PDF through CDRH’s export certification system, CECATS. The part of that definition that is easy to miss: a CFG is an export certificate. It exists to accompany a device leaving the United States. A device that never leaves was never inside its reach — not because FDA doubted the device’s US status, but because the certificate itself only speaks to devices that export.

The 2022 amendment that split the two apart

Section 3304 of the Consolidated Appropriations Act, 2023 (signed December 29, 2022) amended section 801(e)(4) of the FD&C Act to direct FDA to certify devices that are not exported from the United States at all. The certificate it created reaches a specific applicant: a device made by a non-US establishment that never manufactured it on US soil, cleared, approved, or licensed for US marketing (or exempt from premarket submission), registered and listed with FDA the same as any device would be, and shipped from one foreign country directly to another, with the United States never part of the route. That is a second, distinct certificate for exactly the applicant a standard CFG structurally excludes — not a waiver of the export requirement, but a separate certification built around its absence.

Why the distinction is worth tracking

A company that manufactures entirely abroad and distributes entirely abroad, while holding a US clearance or approval on the same product line, used to have no certificate to hand a foreign regulator asking for proof of that US status — the device qualified for US marketing but generated no export record, and no export record meant no CFG. The 2022 amendment did not change anything true about the device. It changed what FDA could put on paper about a device that had never physically been in the United States to begin with.

The device’s US status did not change in 2022. What FDA could certify about a device that never left a foreign factory did.

The practice

Before telling a foreign distributor or regulator that no US export certificate applies because the device never touches US soil, check which certificate the question is actually asking about. “We don’t export from the US” ended that conversation before 2022. It does not end it now.

This is regulatory intelligence and method, not a determination about any specific device or shipment — which certificate a given product and distribution pattern actually qualifies for is a question for your regulatory affairs team, working from the current CECATS requirements.