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  1. Exporting Medical Devices

Other Export Documents

Overview

The Export Reform and Enhancement Act of 1996 authorized the Food and Drug Administration (FDA) to permit the export of certain medical devices, including radiation emitting electronic products that are medical devices, that are not authorized to be legally marketed in the United States (U.S). It also authorized FDA to receive notification for the export of certain medical devices. The Center for Devices and Radiological Health (CDRH) processes these export documents as Export Permit Letters or as Simple Notifications.


Export Permit Letter Under Section 801(e)(2) of the FD&C Act

An Export Permit Letter is issued by CDRH in accordance with Section 801(e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). An Export Permit Letter is for the export of Class III investigational devices, banned devices, and/or unapproved devices for which a Premarket Approval (PMA) Application has not been submitted to CDRH (or for which a PMA has not been approved) and that do not meet the criteria under Section 802 of the FD&C Act for a Certificate of Exportability. These devices must meet the requirements under Section 801(e)(1) of the FD&C Act, and the export of these devices must not be contrary to public health and safety. In addition, the devices must have the approval of the country receiving the exported device.

The types of devices permitted for export under Section 801(e)(2) include those that:

  • Do not comply with applicable requirements of Section 514 (performance standards) of the FD&C Act;
  • Do not comply with applicable requirements for an approved Premarket Approval Application under Section 515 or performance standards under 514 of the FD&C Act;
  • Are exempt from Sections 514 (performance standards) and 515 (premarket approval) of the FD&C Act according to Section 520(g) of the FD&C Act; or
  • Are banned from the U.S. market under Section 516 of the FD&C Act.

The device must meet the following criteria under Section 801(e)(1) of the FD&C Act to be exported:

  • Meet the specifications of the foreign purchaser;
  • Should not be in conflict with the laws of the country to which it is intended for export;
  • Should be labeled on the outside of the shipping package that it is intended for export; and
  • Should not be sold or offered for sale in U.S. domestic commerce.

In order to export under Section 801(e)(2) of the FD&C Act, a firm must apply for and receive an Export Permit Letter from the FDA. FDA must determine that the exportation of the device is not contrary to public health and safety and the device has the approval of the country receiving the exported device.


Export Permit Letter Under Section 802(c) of the FD&C Act

Medical devices may be exported under an Investigational Device Exemption (IDE), e.g., instances in which clinical investigations are being conducted outside the United States. As per Section 802(c) of the FD&C Act, the export of a medical device for investigational use in any Tier 1 country listed in Section 802(b)(1)(A)(i) and (ii) of the FD&C Act may proceed in accordance with the laws of that country and is exempt from regulation under the IDE requirements of section 520(g) of the FD&C Act. These unapproved devices may be exported without FDA authorization if the unapproved device is exported in accordance with the laws of the country receiving the device. Devices being exported under Section 802(c) of the FD&C Act are not required to meet the requirements of the IDE regulation under 21 CFR 812. However, the establishment and the device must meet the requirements of Section 802(f) of the FD&C Act.

Export of an unapproved device for investigational use to any country other than the countries listed in Section 802(b)(1)(A)(i) and (ii) of the FD&C Act requires an export permit, by the FDA under section 801(e)(2) of the FD&C Act. The device must meet the following criteria under section 801(e)(2) of the FD&C Act:

  • The device meets the requirements under Section 801(e)(1) of the FD&C Act;
  • 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.

An Export Permit Letter may be requested by following the steps outlined in, "How to Request Export Certificates or Permits and How to Submit Simple Notifications".


Simple Notification

While the FDA does not require a firm to obtain written permission prior to export under Section 802 of the FD&C Act, firms exporting a device under Section 802 must provide written notification to the FDA when the exporter first begins to export the device.

The notification must identify:

  • The device’s trade name;
  • The type of device;
  • The device’s model number; and
  • The country that is to receive the exported device if the export is to a non-Tier 1 country (country not included in the Tier 1 countries listed below).

If the export is intended for a Tier 1 country, then the notification may, but is not required to, identify the country receiving the device, or it may state that export is to a Tier 1 country without identifying the listed Tier 1 country.

Tier 1 countries enumerated in Section 802(b)(1)(A)(i) and (ii) of the FD&C Act are: Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, the European Union, or a country in the European Economic Area (the countries in the European Union and the European Free Trade Association).

A Simple Notification may be submitted by following the steps outlined in, "How to Request Export Certificates or Permits and How to Submit Simple Notifications".

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