- Non-tier one countries
- Recordkeeping Requirements for All Exported Investigational Devices
A person who imports or offers to import an investigational device shall be considered an agent for the foreign exporter and shall either act as the sponsor of the clinical investigation or ensure that another person acts as the agent and the sponsor of the investigation. That is, the sponsor of an IDE MUST be located in the United States. See "Responsiblities for Sponsors" for further information. Any investigational device imported into the U.S. must be labeled and used in accordance with FDA regulations.
FDA has jurisdiction over the export of unapproved devices exported for use in foreign studies. Please note that FDA does not have jurisdiction over the manner in which the investigational study is conducted outside the U.S. and an IDE is not necessary for a study conducted entirely at foreign sites. However, 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. (See Frequently Asked Questions for more information on FDA acceptance of foreign data.)
Export of an investigational device is subject to the provisions set forth in sections 801(e) and 802 of the FD&C Act. The export of investigational medical devices follows a two tiered system depending on the country to which the device is exported. Products may be exported under 802 of the Act to tier one countries or under 801(e) of the Act to non-tier one countries. Under 801(e), it may be necessary to obtain FDA approval prior to export.
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
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.
Export under 801(e)(2) of the FD&C Act. 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 (noted above) 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 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.
The requester should flag the request "Export Request" and send it, along with any questions concerning the export of medical devices to:
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Division of Risk Management Operations
Regulatory Policy and Systems Branch
10903 New Hampshire Avenue
WO66 Room 2621
Silver Spring, MD 20993-0002
If the device is regulated by CBER, please contact them for further assistance at either 1-800-835-4709 or Industry.Biologics@fda.hhs.gov
Please note that in addition to medical devices exported for use in investigational studies, any unapproved Class III device which is not authorized for distribution in a tier one country may not be exported to a non tier-one country under any circumstances without first obtaining permission from FDA through a request for export under 802(e)(2).
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.