The Workbench · Craft
A device can earn this FDA certificate without a US sale
This blog has already drawn the line between a Certificate to Foreign Government, which exports a fact FDA already established about a device's domestic clearance, and a Certificate of Exportability, which covers a device that skipped that review under a named statutory carve-out. Both documents share one assumption neither one states outright: the device is leaving the United States. A device built at a contract manufacturer's plant abroad, cleared under a 510(k) a US-based sponsor filed, and shipped straight from that plant to a buyer in a third country never crosses that threshold at all — and until a 2023 statutory change, a device in exactly that position had no certificate FDA could issue on its own authority, cleared or not.
Two certificates, the same geography
A Certificate to Foreign Government runs on Section 801(e)(4)(A) of the FD&C Act, and a Certificate of Exportability runs on Sections 801(e)(1) and 802 — different statutory conditions, but the same geography. Each one presumes the certified device is physically departing the United States, because each one is built to answer a foreign buyer's or regulator's question about a shipment crossing that specific border. Neither provision has anything to say about a device that was never here to begin with.
Clearance and marketing used to have to travel together
A standard CFG required the device be legally marketed in the United States — not merely cleared on paper, but actually in US commercial distribution. A device cleared under a 510(k) or approved under a PMA, but manufactured and sold exclusively through facilities and customers outside the US, never met that bar, because “legally marketed” was read against actual US commerce, not against the fact of FDA's own review. That same device couldn't fall back on a Certificate of Exportability either, since that certificate exists for devices that skipped US premarket review altogether under Section 801(e)(1) — and this device hadn't skipped review. It had cleared it. The device sat in a gap neither certificate was written to reach: reviewed by FDA, yet without a document FDA could issue saying so.
Section 3304 named the gap and closed it
Section 3304 of the Consolidated Appropriations Act, 2023 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, where specific conditions are met. The result is the Certificate to Foreign Government for Device Not Exported from the United States — a CFG-NE — available for a device manufactured outside the US that's cleared, approved, or licensed, or that isn't required to submit a premarket report in the first place, shipped from outside the US directly to another foreign country. The device never touches US soil in either direction, and the certificate doesn't require that it does.
The underlying conditions didn't get lighter, just untethered from shipping
A CFG-NE isn't a weaker certificate issued because the shipping route is simpler. The requesting establishment and every manufacturing site in the chain — the manufacturer, any contract manufacturer, any contract sterilizer — still has to be identified and registered under Section 510 of the FD&C Act, the device still has to be listed, and the registering establishment still has to be in substantial compliance with the Quality System Regulation at 21 CFR Part 820. FDA can deny a CFG-NE on the same quality-system grounds it uses to deny a standard CFG, including a finding of major noncompliance under the agency's own Compliance Program Guidance Manual, with the same route open afterward: a written plan of correction addressing the specific deficiencies cited in FDA's response.
Filed the same way, decided on the same compliance facts
A CFG-NE request runs through CDRH's Export Certification Application and Tracking System, the same portal that handles standard CFGs and Certificates of Exportability, under the same $175-for-the-first-certificate, $85-for-each-additional fee structure and the same statutory 20-day processing clock. Certificates issue electronically rather than as notarized paper, and run for two years from issuance — identical mechanics to the other two certificate types, because the thing that changed in 2023 was eligibility, not process.
Where this meets the file
An export-documentation tracker built around a device's marketing status — the status field this blog has already argued belongs in that file — now needs a fourth value alongside cleared-and-marketed, cleared-and-not-marketed, and exempt: manufactured and shipped entirely outside the United States, mapped to CFG-NE eligibility specifically rather than folded into a device's domestic marketing status. An export-readiness worksheet built around that fourth value is previewed in the launch catalog. If your program has requested a CFG-NE and tracks its conditions differently, the shelf takes that correction directly.
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