Import and Export of Investigational Devices Non-Tier One Countries

Export under 801(e) (2) of the FD&C Act. The exporter must submit information to FDA that would enable the agency to determine that exportation is not contrary to the public health or safety and that the foreign country approves of the exportation.

In order for FDA to make the determination that export is not contrary to the public health and safety, manufacturers are required to submit with their export requests basic data regarding the safety of the device.

There are two circumstances in which FDA does not recommend the submission of safety data with an export request:

• the device has an FDA-approved investigational device exemption (IDE) and will be marketed or used for clinical trials in the importing country for the same intended use
• the manufacturer has been informed by an Institutional Review Board (IRB) in the U.S. that the device is a non-significant risk device and the device will be marketed or used for clinical trials in the importing country for the same intended use.

To determine whether exportation of the device has approval of the country to which it is intended for export, a letter from the foreign country approving importation is required. Official foreign government liaisons are contained in the CDRH Foreign Liaison Listing. If the manufacturer is exporting to a country within the European Economic Area (EEA) a device that has been awarded the "CE mark," FDA will accept documentation of the "CE mark" in lieu of a letter from the foreign government approving importation.

To obtain FDA's approval to export investigational devices to these countries, a request that includes the following information must be submitted to FDA:

• A complete description of the device intended for export
• The status of the device in the U.S. e.g., whether it is investigational, banned, etc.
• A letter from the appropriate foreign liaison (person with authority to sign a letter of acceptance for the foreign government identified in the CDRH Foreign Liaison Listing), which must be either in English or accompanied by a certified English translation, stating:
• the device is not in conflict with the laws of the country to which it is intended for export
• the foreign government has full knowledge of the status of the device in the U.S.; and
• import is permitted or there is no objection to the import of the product.