US FDA Export Rules for Used and Refurbished Medical Devices

U.S.-based exporters of used and refurbished medical equipment must navigate a distinct set of Food and Drug Administration (FDA) rules that determine what can be legally shipped abroad, and under what conditions. These rules are separate from — and sometimes confused with — the FDA's domestic marketing clearance system. Understanding the difference between devices that are "legally marketed" in the U.S. and devices that are "export only" is essential for any company selling refurbished hospital equipment internationally.

This article summarizes the FDA's export framework as it applies to used and refurbished medical devices, including the four export certificate types, the export-only pathway under Section 801(e), and what exporters must document.

The Legal Foundation: Export Reform and Enhancement Act of 1996

The Export Reform and Enhancement Act of 1996 gave the FDA authority to issue export certificates confirming that a device meets specified requirements, and clarified the statutory pathways under which devices can leave the U.S. even if they cannot be sold domestically. The FDA's Center for Devices and Radiological Health (CDRH) administers these certificates and pathways (FDA: Types of Export Certificates).

Broadly, there are two categories of export scenario for a used device exporter:

1. The device is legally marketed in the U.S. (i.e., it could be sold domestically) — export is essentially unrestricted, and a Certificate to Foreign Government (CFG) can be requested to prove this to a foreign regulator or customs authority.
2. The device is not legally marketed in the U.S. (e.g., it was never cleared/approved, or it is a device the exporter chooses not to market domestically) — it may still be exportable under Section 801(e)(1) or Section 802 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), provided specific conditions are met.

Certificate to Foreign Government (CFG)

A CFG applies to devices that can be legally marketed in the U.S. To request one, the exporting establishment must meet these conditions (FDA: Types of Export Certificates):

• The establishment is registered with the FDA.
• The device is listed with the FDA.
• The device has a cleared 510(k), an approved PMA (unless exempt), predates the 1976 Medical Device Amendments, or received a De Novo classification.
• The device meets labeling requirements under 21 CFR Part 801 (general device labeling) or 21 CFR Part 809 (in vitro diagnostics), as applicable.
• The device is manufactured in accordance with the Quality Management System Regulation (21 CFR Part 820), unless exempted.

By applying for a CFG, the establishment certifies the device is not subject to an open recall and that all manufacturing facilities involved comply with applicable FDA regulations. Any device legally marketed in the U.S. may be exported anywhere in the world without prior FDA notification or approval — the CFG is a supporting document often requested by foreign customs or health authorities, not a precondition to export itself.

For a refurbisher of used equipment, this means: if the original device received FDA clearance/approval when new, and the exporting establishment maintains its registration/listing and follows labeling and quality system rules during refurbishment, the used unit generally remains exportable under the CFG pathway.

Certificate of Exportability under Section 801(e)(1)

Devices that are not legally marketed in the U.S. — because they lack 510(k) clearance, PMA approval, or De Novo classification, or fall outside an applicable exemption — can still be exported legally under Section 801(e)(1) of the FD&C Act, without needing prior FDA permission, if the device (FDA: Types of Export Certificates):

• Is a Class I or Class II device;
• Accords with the specifications of the foreign purchaser;
• Does not conflict with the laws of the destination country;
• Is labeled on the outside of the shipping package as intended for export; and
• Is not sold or offered for sale in the United States.

This pathway is particularly relevant for refurbished units that a company may configure or relabel specifically for a foreign buyer's specifications and never offer domestically. A device pending 510(k) review may also be exported under Section 801(e)(1) if there is a reasonable expectation that the FDA would eventually clear it, based on similarity to an already-cleared device.

Important limitation: a device that was sold or offered for sale in the U.S. and later found to be adulterated or misbranded cannot be "exported around" the problem under Section 801(e)(1) as an alternative to bringing it into compliance. Establishments applying for a Certificate of Exportability under this section must register and list their device, and must sign a statement certifying they meet the 801(e)(1) criteria — false statements are a federal offense under 18 U.S.C. § 1001.

Certificate of Exportability under Section 802

Section 802 covers a narrower, higher-risk category: unapproved Class III devices and Class II devices subject to mandatory performance standards, including investigational devices and devices that failed to obtain PMA approval. To qualify, in addition to meeting the Section 801(e)(1)-style criteria above, the device must also (FDA: Types of Export Certificates):

• Substantially conform to the Quality Management System Regulation or an internationally recognized quality standard;
• Not be adulterated for any reason other than lacking U.S. marketing authorization;
• Not be subject to an HHS notice that re-importation would pose an imminent hazard;
• Comply with the laws of the receiving country; and
• Have valid marketing authorization from the medical device authority of a "Tier 1" country — Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, the European Union, or a European Economic Area/EFTA country.

Section 802 also addresses related situations: export for investigational use in a Tier 1 country, export for further processing pending marketing authorization, and export of devices intended to treat diseases not prevalent in the U.S. (subject to separate FDA risk-benefit review). Most used/refurbished general hospital equipment (ultrasound systems, patient monitors, imaging equipment) will not require this pathway unless the specific model was never cleared or was subject to a compliance action in the U.S.

Non-Clinical Research Use Only (NCR) Certificate

This certificate applies narrowly to products, materials, or components intended for non-clinical research and not intended for human use. It is not typically relevant to finished, clinically-used hospital equipment being resold for patient care abroad, but exporters occasionally encounter it when exporting components, parts, or bench-top research instruments alongside clinical equipment.

Comparison Table

What Refurbishers Must Document

Regardless of certificate type, a diligent exporter of used medical equipment should maintain a file for each unit or model line including:

• FDA establishment registration number and device listing confirmation.
• Original 510(k)/PMA/De Novo clearance documentation (or evidence the device predates 1976 Amendments), where the CFG pathway applies.
• Refurbishment and quality system records demonstrating conformance to 21 CFR Part 820 (or applicable international equivalent, such as ISO 13485).
• Confirmation of no open recall on the specific device or model.
• Export-only labeling on shipping cartons, when applicable under Section 801(e)(1) or 802.
• Buyer specification records, where the export-only pathway depends on customization to the foreign purchaser's requirements.
• The relevant export certificate (CFG, COE 801, or COE 802), if requested by or required for the destination country's customs or health authority.