INTERNATIONAL TRADE LAW
Exporting Medical Devices: FDA Export Rules
Whether you can export a medical device from the U.S. — and what paperwork you need — depends almost entirely on one question: can the device be legally marketed in the United States? If yes, export is generally straightforward. If no, you can still export, but only under specific Food, Drug, and Cosmetic (FD&C) Act provisions and, in some cases, with FDA authorization. Getting this threshold question wrong is the central compliance risk in device exports.
This guide covers the FDA framework that governs device exports, plus the export-control and filing steps that apply to any shipment.
Start with one question: is the device legal to sell in the U.S.?
The FDA splits device exports into two paths.
Devices that may be legally marketed in the U.S. (cleared via 510(k), approved via PMA, or otherwise compliant) can generally be exported without FDA export approval. You don’t need a special FDA sign-off to ship them — though the destination country may ask you to prove the device’s U.S. status with an export certificate (below).
Devices that may not be legally marketed in the U.S. (unapproved, investigational, or banned) can still be exported, but only under the FD&C Act’s export provisions:
| Provision | Applies to | Core conditions |
|---|---|---|
| Section 801(e)(1) | Devices not in compliance with U.S. marketing requirements | Meets the foreign buyer’s specs; not in conflict with the destination country’s laws; labeled for export; and not sold in U.S. domestic commerce |
| Section 802 | Certain unapproved Class III devices, devices needing a performance standard, and banned devices | Export to listed/eligible countries with added conditions; may require a Certificate of Exportability and FDA notification |
If your device falls outside what can be legally marketed here, identify which provision you are relying on before you ship, and confirm you meet every condition.
FDA export certificates: what they are and who issues them
Foreign customers and governments frequently require an FDA certificate confirming the device’s U.S. regulatory status. For devices, these are issued by the Center for Devices and Radiological Health (CDRH):
- Certificate to Foreign Government (CFG) — confirms a device can be legally marketed in the U.S. Used for exportable, marketable devices.
- Certificate of Exportability (COE) — issued for devices that cannot be legally marketed in the U.S. but meet the Section 801(e) or 802 export conditions.
These certificates are requested through FDA’s electronic certificate system (CDRH issues them for medical devices). They are about the device’s FDA status — they are separate from the export-control and customs steps below.
Export controls and filing still apply
FDA status answers the health question. You also have to clear the trade rules that apply to any export:
- Export classification. Most medical devices are EAR99 under the Export Administration Regulations and need no Bureau of Industry and Security license to most destinations. Some devices and their technology carry an ECCN (for example, certain devices with controlled software or dual-use components) — classify, don’t assume.
- Party and destination screening. Screen the buyer, consignee, and end user against the OFAC SDN list, BIS Entity List, and Denied Persons List, and confirm the destination is not embargoed.
- EEI filing. File Electronic Export Information through AES when the value under a single Schedule B number exceeds $2,500, or whenever a license is required.
A clean device-export sequence
- Determine whether the device can be legally marketed in the U.S.
- If not, identify your export pathway (Section 801(e) or 802) and confirm every condition.
- Obtain the right FDA certificate (CFG or COE) if the destination requires one.
- Classify the device under the EAR (usually EAR99; verify).
- Screen parties and destination; confirm no embargo applies.
- File EEI in AES when required, and ship with accurate documentation.
Frequently asked questions
Do I need FDA approval to export a device that’s already cleared in the U.S.? No. Devices that may be legally marketed in the U.S. can generally be exported without separate FDA export approval. You may still need a Certificate to Foreign Government if the importing country asks for one.
Can I export a device the FDA hasn’t approved? Often yes, under Section 801(e) or Section 802 of the FD&C Act — but only if you meet their conditions (such as conforming to the foreign buyer’s specifications, not conflicting with destination-country law, and proper export labeling). Some require a Certificate of Exportability.
What’s the difference between a CFG and a COE? A Certificate to Foreign Government covers devices that can be legally marketed in the U.S.; a Certificate of Exportability covers devices that cannot be but qualify to export under the Act.
Do export controls apply to medical devices? Yes. Most are EAR99 with no license needed to most destinations, but you must still classify the device, screen the parties, and avoid embargoed countries.
Exporting medical devices and need the FDA pathway and filing steps mapped out? Reidel Law Firm provides a flat-fee Import/Export Compliance Memo that confirms your device’s export pathway, certificates, and screening obligations in plain English. Get an import/export compliance memo →
