Recordkeeping Requirements for All Exported Investigational Devices

The exporter must maintain records of all devices exported and the countries to which they were exported. FDA has proposed in a Federal Register notice dated April 2, 1999, "Exports: Notification and Recordkeeping Requirements," that these records include the product’s name, type of device, consignee name and address, date and quantity exported. In addition, the exporter must maintain documentation that the device meets the requirements of section 801(e)(1). FDA has proposed that these records be maintained at least 5 years after date of exportation.

Exports: Notification and Recordkeeping Requirements

The FDA Export Reform and Enhancement Act established recordkeeping and notification requirements. Section 802(g) of the act requires an exporter of a device under section 802(b)(1)(A) of the act to provide a "simple notification" to the agency "identifying the device when the exporter first begins to export such device" to any of the 25 countries identified in section 802(b)(1)(A) of the act. For exports to other, nonlisted countries, section 802(g) of the act requires the exporter to provide a simple notification "identifying the device and the country to which such device is being exported."This section also requires persons exporting devices under any provision of section 802 of the act to "maintain records of all devices exported and the countries to which they were exported."

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 regulations. 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

Non-tier one countries

Export of medical devices for investigational use to countries other than those identified above requires that the device meet the requirements of 801(e) of the act. That is, the device must meet the requirements of 801(e)(1) of the act and the exportation must be authorized by the FDA. 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 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.

Related Training:

Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements