Import and Export of Investigational Devices

Tier one countries: Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa or member countries the European Union or of the European Economic Area (EEA) (Export under 802 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 the European Union or of the European Economic Area (EEA) 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 regulation. No notification to FDA is required; however, under section 802 of the FD&C Act these devices;

• must meet the requirements of section 801(e)(1), that is, the device
• must be in compliance with the specifications of the foreign purchaser
• must not be in conflict with the laws of the country to which it is intended for export
• must 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 substantial conformity with current good manufacturing practice requirements or meet international standards as certified by an international standards organization
• 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

Certificate of Exportability

Even though the FDA does not require a firm to obtain written permission prior to export, a firm may find itself in a situation where a foreign purchaser requests proof of compliance with U.S. law prior to export. The FDA will provide a Certificate of Exportability (COE) under section 802 to facilitate export of a medical device under section 802.