Never cleared here. Exported anyway.

A product-code search across 510(k) clearances and PMA approvals answers one question: has this device been found safe and effective, or substantially equivalent, for the U.S. market. It was never built to answer a second, adjacent question a competitor’s device can raise just as easily — is it being sold, lawfully, somewhere else — because U.S. law lets a device leave the country under an entirely different set of rules, rules a domestic clearance search will never surface.

Most devices need no certificate to leave at all

Section 801(e)(1) of the FD&C Act, at 21 U.S.C. § 381(e), sets the general export rule the 1996 Export Reform and Enhancement Act put in place: a device that would otherwise be adulterated or misbranded under U.S. law — because it was never cleared or approved here — can still be exported without FDA’s prior permission and without any certificate at all, provided it meets the foreign purchaser’s own specifications, doesn’t conflict with the importing country’s laws, is labeled on the outside of its shipping package as intended for export, and is never sold or offered for sale inside the United States. No 510(k), no PMA, no FDA sign-off of any kind — just four conditions a manufacturer certifies to itself.

The narrower set that does need one

Section 802, at 21 U.S.C. § 382, carves out the devices Congress judged too consequential for that honor system: banned devices, Class III devices that never received PMA approval, and Class II devices subject to a performance standard. Exporting one of those requires FDA to issue a Certificate of Exportability first — a document that certifies the opposite of what a clearance letter certifies. A 510(k) clearance says a device may be sold in the United States. A Certificate of Exportability says a device may leave the United States precisely because it cannot be.

A different certificate for the opposite claim

CDRH issues a third kind of document, the Certificate to Foreign Government (CFG), for the reverse situation entirely — a device already legally marketed in the U.S., registered and listed, that a foreign regulator wants proof of before allowing it in. A CFG and a Certificate of Exportability answer opposite questions with the same word, “certificate”: one proves a device cleared here, the other proves it didn’t need to. Both are processed through CDRH’s CECATS system, fully electronic since January 2024, and Section 801(e)(4) sets a statutory expectation of a 20-working-day turnaround once a fee is paid.

A K-number says a device may be sold here. A Certificate of Exportability says the opposite is just as lawful: never sold here at all, and still leaving with FDA’s own signature on the paperwork.

The practice

None of FDA Radar’s four sources — 510(k) clearances, enforcement reports, the Federal Register, warning letters — will ever carry an export certificate; neither will openFDA, which doesn’t publish this data at all. A competitor’s device with no K-number and no PMA number isn’t necessarily a device that failed review or was never submitted for one. It can just as easily be a device its maker never intended to sell here, moving under paperwork a domestic clearance search was never built to show. Reading that absence correctly means knowing which of several different things “not in the record” can mean before drawing a conclusion from it — regulatory intelligence about where the record’s edges are, never a determination about a specific competitor’s strategy or a specific device’s compliance, which is a judgment for a regulatory professional with the shipment in front of them.