Export of Investigational Devices

FDA controls the export of unapproved devices for use in foreign studies. FDA does not have say in the way the investigational study is conducted outside the U.S. and an investigational device exemption (IDE) is not required. Though, FDA has authority to accept or deny data that has been collected during a study at a foreign site that is submitted to support a research or marketing application.

Export of an investigational device is subject to the requirements stated in sections 801(e) and 802 of the FD&C Act. It follows a two tiered system depending on the country to which the device is exported. Products may be exported under section 802 of the Act to tier one countries or under section 801(e) of the Act to non-tier one countries.

Tier one countries

It includes Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa or member countries the European Union or of the European Economic Area (EEA).

An unapproved device intended for investigational use may be exported to these tier one countries without FDA authorization if the unapproved device is exported in accordance with the laws of that country. Devices being exported to these countries are not required to meet the requirements of the IDE regulations. No notification to FDA is required; however these devices must meet the requirements of section 801(e)(1) of the FD&C Act, that is, the device.

• must comply with the specifications of the foreign purchaser
• should not clash with the laws of the country to which it is planned for export
• should be labeled on the outside of the shipping package that it is intended for export
• must not be sold or offered for sale in U.S. commerce
• must be manufactured, processed, packaged, and held in compliance with current good manufacturing practice (cGMP )requirements or meet international standards as certified by an ISO
• cannot be adulterated other than by lack of marketing approval
• cannot present an imminent hazard to the public health
• must be labeled and promoted in accordance with the requirements and conditions for use in the country in which the device is intended for export

Non-tier one countries

The export of medical devices for investigational use to non-tier one requires that the device meet the requirements of 801(e) of the act and the FDA must authorize exportation. The exporter should submit information to the FDA to determine that exportation is not contrary to the public health or safety and that the foreign country approves of the exportation.

The FDA does not require the submission of safety data with an export request in some situations such as:

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

A request covering the following information must be submitted to FDA to get approval to export investigational devices to these countries:

• A comprehensive description of the device intended for export
• Device status 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.
• import is permitted or there is no objection to the import of the product.

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