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U.S. Department of Health and Human Services

Medical Devices

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Exporting Unapproved Devices

Background

Chapter VIII of the FD&C Act addresses the FDA’s regulation of the import and export of foods, drugs, cosmetics, biologics, medical devices, and radiation emitting electronic products. Sections 801 and 802 of Chapter VIII list the specific rules governing the import and export of products, including the export of unapproved products.

U.S. manufacturers that export medical devices outside the U.S. are required to register their facility and list their devices even if the devices are not distributed in the U.S. (21 CFR 807). For more information, see Device Registration and Listing.

Exporting Medical Devices Manufactured for Export Only Section801(e)(1)

Requirements

Medical devices that are not FDA approved or cleared for marketing legally in the U.S. may be exported under section 801(e)(1) of the FD&C Act, provided that they are intended for export only. Although such devices do not meet the requirements of the FD&C Act to be sold in the U.S., they may be exported legally and without FDA permission per section 801(e)(1) if they are class I or class II devices and they are:

  • In accordance with the specifications of the foreign purchaser;
  • Not in conflict with the laws of the country to which they are intended for export;
  • Labeled on the outside of the shipping package that they are intended for export; and
  • Not sold or distributed inthe U.S.

A foreign government may require documentation from the FDA confirming that a device meets these criteria and is being exported from the U.S. In these cases, firms may request an export certificate.

A device that is sold or offered for saleinthe U.S. and is then found to be adulterated or misbranded cannot be exported under section 801(e)(1) as an alternative to bringing the device into compliance with the requirements of the FD&C Act. This also applies to devices that have been imported to the U.S. and are later found to be adulterated or misbranded.

Please see the How to Request Exports Certificates/Permits and Submitting Simple Notification section for directions on how to request Certificates of Exportability related to section 801(e)(1) of the FD&C Act.

Exporting Medical Devices While Waiting for FDA Clearance

The FDA is aware that there may be certain devices that firms wish to export while applications for clearance under section 510(k) of the Act under FDA review. The FDA allows the export of a device without 510(k) marketing clearance if it meets two conditions:

  • The device meets the requirements of section 801(e)(1), and
  • There is reasonable expectation that the device could obtain 510(k) marketing clearance in the U.S. if reviewed by the FDA because it is similar in design, construction, and intended use to an already-approved or cleared class I or class II device.

 Devices that would not be included under this consideration are:

  • Pre-Amendment (marketed in the U.S. before May 28, 1976) class III devices for which FDA has called for the submission of a PMA ;
  • Post-Amendment (marketed in the U.S. after May 28, 1976) class III devices; or
  • Devices evaluatedby a firmand found to be not substantially equivalent to an existing 510(k) device.

Recordkeeping Requirements

Firms exporting a product under section 801(e)(1) of the FD&C Act must maintain records demonstrating that the product meets specified requirements, as must firms distributing a product otherwise subject to section 801(e)(1). All records must be retained for a period of time equivalent to the expected life of the device, but at minimum two years from the date of release of the device for commercial distribution by the manufacturer (21 CFR 820.180). The records must be made available to the FDA, upon request, during an inspection for review and copying by the FDA. They include:

  • Records demonstrating that the product meets the foreign purchaser's specifications. The records must contain sufficient information to match the foreign purchaser's specifications to a particular export;
  • Records demonstrating that the product does not conflict with the laws of the importing country. This may consist of either a letter from an appropriate foreign government agency, department, or other authorized body stating that the product has marketing approval from the foreign government or does not conflict with that country's laws, or a notarized certification by a responsible company official in the United States that the product does not conflict with the laws of the importing country and that includes a statement acknowledging that he or she is subject to the provisions of making false statements to the government under 18 U.S.C. 1001;
  • Records demonstrating that the product is labeled as intended for export on the outside of the shipping package. This may consist of copies of any labels or labeling statements, such as “For export only,'' that are placed on the shipping packages or, if the exported product does not have a shipping package or container, on shipping invoices or other documents accompanying the exported product; and
  • Records demonstrating that the product is not sold or distributedin the U.S. This may consist of production and shipping records for the exported product and promotional materials.

Additional guidance can be found in the Regulatory Procedures Manual as well as section 801 of the FD&C Act.

Exporting Unapproved Class III devices and Class II Devices via Section 802

Requirements

Unapproved Class III devices and Class II devices that are required to meet performance standards under section 514 of the FD&C Act may be exported under section 802 of the FD&C Act if the firms and the devices meet certain criteria. These include investigational devices, unapproved devices that could not obtain a PMA (or for which a PMA has not been approved), and banned devices. Electrode lead wires and patient cables (21 CFR 898) are currently the only devices subject to an FDA performance standard under section 514 of the FD&C Act. Currently, the only banned medical devices are synthetic hair fibers intended for implant. 
In order to qualify for export under section 802, devices must be class II or class III and meet the requirements under section 801(e)(1). Specifically, the devices must:

  • Be in accordance with the specifications of the foreign purchaser;
  • Be labeled as intended for export on the outside of the shipping package;
  • Not be in conflict with the laws of the country to which they are intended for export;
  • Not be sold or offeredin the U.S.

The devices must also pass the restrictions established in section 802(f). Specifically the devices must:

  • Substantially meet the Quality System Regulation (also known as Good Manufacturing Practice requirements) or an international quality standard recognized by the FDA (currently, none are recognized),
  • Not be adulterated, other than by the lack of U.S. marketing approval,
  • Not be the subject of a notice by the Department of Health and Human Services that re-importation would pose an imminent hazard, nor pose an imminent hazard to the receiving country, and
  • Not be mislabeled (in this case, labeling with the language, units of measure, or any other labeling authorized by the recipient country is permitted.)

In addition, the device must comply with the laws of the receiving country and have valid marketing authorization by the appropriate authority in a listed Tier 1 country (see below). This means that a firm whose device has received marketing authorization in any  Tier 1 country can export that device to any country in the world (including the U.S.), as long as the device meets applicable requirements of the FD&C Act. Additionally, the marketing authorization by the Tier 1 country must be acceptable to the appropriate authorities in the importing country. Some South American countries, for example, now permit marketing of any medical device with a CE (“European Community”) mark, indicating that the associated product complies with European Union legislation.  If the appropriate authorities of a non-Tier 1 country will not accept the marketing authorization of a Tier 1 country, then the exporter can obtain a permit under section 801(e)(2).

Listed (Tier 1) Countries

The listed, or Tier 1, countries are: Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, a member of the European Union (United Kingdom, Spain, Ireland, Denmark, Greece, Belgium, Portugal, Germany, France, Italy, Luxembourg, Netherlands, Sweden, Finland, Austria, Bulgaria, Romania, Cyprus, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia, and Slovenia), or the European Economic Area (includes the European Union countries and Norway, Iceland, and Liechtenstein).

If the firm or device does not comply with the above criteria, the device cannot be exported under section 802. However, the device may qualify for exportation under section 801(e)(2).

The complete requirements of section 802 can be found in the FD&C Act and a detailed discussion is contained in the Regulatory Procedures Manual.

Simple Notification and Export Certificates

Exporting under section 802 does not require prior approval from the FDA (i.e., applying for and obtaining an Export Permit Letter). Instead, the exporter must submit a "Simple Notification" to the FDA, per section 802(g), when the firm begins to export.

The notification must identify:

  • The product's trade name;
  • The type of device;
  • The product's model number; and
  • The country that is to receive the exported article if the export is to a country not listed (non-Tier 1 country).

The notification may, but is not required to, identify the listed Tier 1 countries or may state that the export is intended for a listed Tier 1 country without identifying the listed country.

Even though FDA does not require a firm to obtain written permission prior to export under section 802, a foreign purchaser may request proof of compliance with U.S. law prior to export. FDA will provide a Certificate of Exportability (COE) to the exporter under section 802 to facilitate export of a medical device.  How to Request Export Certificates/Permits and Submitting Simple Notification provides more detailed instructions on submitting simple notification and requesting COEs under section 802.

Recordkeeping Requirements

Anyone exporting a product under any provision of section 802 of the FD&C Act shall maintain records [section 802(g)] of all devices exported and the countries to which the products were exported. In addition to the requirements in 801(e)(1) noted above, such records include, but are not limited to, the following:

  • The product's trade name;·
  • The type of device;
  • The product's model number;
  • The consignee's name and address; and
  • The date on which the product was exported and the quantity of product exported.

These records must be kept at the site from which the products were exported or manufactured. All records must be retained for a period of time equivalent to the expected life of the device, but at minimum two years from the date of release for commercial distribution by the manufacturer (21 CFR 820.180). The records must be made available to the FDA, upon request during an inspection, for review and copying by the FDA.

Additional Provisions under section 802

There are additional situations where section 802 applies. These include:

  • Devices exported for investigational use - Medical devices may be exported under an Investigational Device Exemption (IDE), e.g.,  instances in which clinical investigations are being conducted abroad. As per section 802(c), the export of a medical device for investigational use in any Tier 1 country may proceed in accordance with the laws of that country and is exempt from regulation under the IDE statutory requirements of the FD&C Act [section 520(g)]. Additional guidance can be found in Exporting for Investigational Use as well as in Section 802 of the FD&C Act.
  • Exported devices intended for further processing - As per section 802(d), a medical device intended for further processing pending expected marketing authorization from a listed Tier 1 country may be exported for use in that country. The fundamental concept is that the device is being exported in anticipation of marketing approval. Additional guidance can be found in Exporting for Marketing or in Anticipation of Foreign Marketing Approval , as well as Section 802 of the FD&C Act.
  • Devices intended for treatment of diseases not prevalent in the U.S. - As per section 802(e)(1), a medical device intended for the diagnosis, treatment, or prevention of a tropical or other type of disease not prevalent in the U.S., which does not otherwise meet section 802 criteria, may be exported with an FDA approved application for export if the FDA finds that:
    • The device does not present unreasonable risk;
    • The benefits outweigh the risks; and
    • The risks of using available alternatives were considered.

Additional guidance can be found in the Regulatory Procedures Manual as well as Section 802 of the FD&C Act.

Exporting Unapproved Class III devices and Class II Devices via Section 801(e)(2)

Requirements

Class III investigational devices, banned devices, and unapproved devices for which a PMA has not been submitted to CDRH (or for which a PMA has not been approved), which do not meet the criteria under section 802, may qualify for export under section 801(e)(2).
The types of devices subject to section 801(e)(2) include ones that:

  • Do not comply with section 514 (performance standards) of the FD&C Act;
  • Require an approved Premarket Approval but do not have one;
  • Are undergoing clinical investigation; or
  • Are banned from the U.S. market under Section 516 of the FD&C Act.

Currently, electrode lead wires and patient cables are the only devices with an FDA performance standard (21 CFR 898) and synthetic hair fibers intended for implant are the only banned medical devices (21 CFR 895).
Export must take place as outlined in section 801(e)(2) if any of the following conditions apply:

  • The importing country will not accept the marketing authorization of a listed (Tier 1) country as described in Section 802;
  • The intent is to conduct clinical investigations in a country not listed in section 802; or
  • The device is not manufactured in substantial conformance with the Quality System Regulation.

The device must meet the following criteria to be exported:

  • The device must meet the requirements under section 801(e)(1) of the FD&C Act. That is:
    • In accordance with the specifications of the foreign purchaser;
    • Not in conflict with the laws of the country to which it is intended for export;
    • Labeled on the outside of the shipping package that it is intended for export; and
    • Not sold or distributedin domestic commerce (in the U.S.).
  • A review by the FDA must determine that the exportation of the device is not contrary to public health and safety.
  • The device has the approval of the country to which it is intended for export.

In order to export under section 801(e)(2), a firm must apply for and receive an export permit from the FDA. How to Request Export Certificates/Permits and Submitting Simple Notification provides directions on obtaining an export permit related to section 801(e)(2) of the FD&C Act.

Exporting for Investigational Use

A manufacturer wishing to export an unapproved device for investigational use may export the device through an Investigational Device Exemption (IDE) under sections 801(e)(2) or under 802(c) of the FD&C Act, depending on the device’s destination. 

Under section 802(c) of the FD&C Act, an unapproved device intended for investigational use may be exported to Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, or member countries of the European Economic Area (EEA) without FDA authorization if the unapproved device is exported in accordance with the laws of the importing country. Devices being exported under section 802(c) are not required to meet the requirements of the IDE regulation under 21 CFR 812. However, the firm and the device must meet the requirements of section 802(f).

Exportation of an unapproved device for investigational use to any country other than the countries identified above requires authorization, in the form of an export permit, by the FDA under section 801(e)(2). The device must meet the following criteria under section 801(e)(2):

  • The device meets the requirements under Section 801(e)(1);
  • A review by FDA determines that the exportation of the device is not contrary to public health and safety; and
  • The device has the approval of the country to which it is intended for export.

Please refer to section 801(e)(2) above for additional guidance.

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Exporting in Anticipation of Foreign Marketing Approval

Section 802(d) of the FD&C Act permits the exportation of an unapproved drug, biologic, or device "intended for formulation, filling, packaging, labeling, or further processing in anticipation of market authorization" in any of the listed countries. The only requirement for such exports is that the products comply with the laws of the foreign country and the requirements in section 802(f) of the FD&C Act. Records for such exports must be kept in accordance with section 802(g) of the FD&C Act. Please refer to section 802 for further guidance.