The Workbench · Craft
Which export certificate you get depends on one fact
This blog has already covered how FDA registration and device listing are two separate duties a firm owes before it can sell in the U.S. at all, and the separate duties an importer takes on once a device crosses the border the other direction. A device leaving the country the direction those posts don't cover runs into its own paperwork: an FDA export certificate a foreign customs authority or purchaser wants to see. FDA issues more than one kind, and a request for the wrong one doesn't fail on the merits — it fails because the device's own U.S. marketing status never supported that certificate in the first place.
A Certificate to Foreign Government only reaches devices already cleared or approved here
A Certificate to Foreign Government (CFG) is FDA's attestation that a specific device is legally marketed in the United States and that the establishment manufacturing it is in good standing — registered, and, where the device's classification calls for it, cleared or approved. That's the whole premise of the document: it exports a fact FDA already established during the device's domestic review, for the benefit of a foreign regulator who wants FDA's own word on it rather than the manufacturer's. A device still sitting in an open 510(k) or PMA review has no such fact for the CFG to export, no matter how confident the sponsor is that clearance is close.
A Certificate of Exportability covers exactly the devices a CFG can't reach
Section 801(e)(1) of the FD&C Act sets the conditions under which a Class I or Class II device, or one exempt from premarket review, can leave the country without ever having gone through the review a U.S. sale would require: the manufacturing establishment has to be registered and the device listed with FDA, the device has to meet the specifications of the foreign purchaser, it can't conflict with the law of the importing country, and it has to be labeled as intended for export. Section 802 covers the adjacent case — a device subject to a performance standard under section 514 that isn't legally marketed domestically — on a similar structure. A Certificate of Exportability attests to compliance with one of those two sections, not to U.S. marketing status, because the device the certificate covers doesn't have any.
The two documents are answering opposite starting facts
That's the whole distinction, and it's easy to lose in a shipping department that just wants “the export paperwork” for whatever's going out the door. A CFG's entire evidentiary weight comes from a review FDA already completed; a Certificate of Exportability's weight comes from a statutory carve-out that lets a device skip that review precisely because it's leaving instead of staying. Asking for a CFG on a device that was exempted from premarket review under 801(e)(1) doesn't get a faster answer — it gets a rejection, because the device never went through the clearance or approval process the CFG exists to certify.
Filed the same way, decided on a fact the portal doesn't check
Both certificate types are requested through the same system, CDRH's Export Certification Application and Tracking System, and since January 2, 2024 FDA issues both electronically rather than as notarized paper documents. Certificates run for two years from the date of issuance. None of that shared mechanics answers the eligibility question up front — the system doesn't stop a requester from filing for a CFG on a device that was never cleared, it just returns a request FDA can't grant. The eligibility check is the applicant's to run before filing, not the portal's to catch afterward.
The request usually starts with someone who isn't the manufacturer
A CFG or a Certificate of Exportability is rarely something a regulatory team decides on its own to go get. Most requests start with a foreign distributor, a customs broker abroad, or the importing country's own regulator asking a U.S. manufacturer for one, often naming the specific certificate type their own registration process requires. That request arrives without any obligation to have gotten the type right — the person asking is applying their own country's paperwork checklist, not FDA's eligibility rule, and a regulatory team that fills whichever request lands on its desk without checking the device's own marketing status against it is letting a foreign customer's assumption stand in for FDA's actual requirement.
Where this meets the file
An export-documentation tracker needs a field for the device's actual U.S. marketing status — cleared, approved, exempt-and-not-marketed, or exempt-and-marketed — tied directly to which certificate that status supports, rather than a single “export certificate requested” checkbox that treats the two documents as interchangeable paperwork. An export-readiness worksheet built around that status field is previewed in the launch catalog. If your team tracks export certificate eligibility differently, the shelf takes that correction directly.
The Regulatory Toolkit launches soon — a free shelf of source-mapped templates, checklists and browser-only tools for regulatory teams. Get one email when it opens, or contribute a template.