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Import/Export
Import and Export of Investigational Devices
Import
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.
Export
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 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, and
- 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.
Non-tier one countries Export under 801(e)(2) of the
FD&C Act
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; or
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.; and
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 (HFZ-307)
2094 Gaither Road
Rockville, Maryland 20850
Telephone Number (240) 276-0132
exportcert@cdrh.fda.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).
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 products 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.
References
ยง
812.18
Device Advice "Exporting Medical Devices"
http://www.fda.gov/cdrh/devadvice/39.html.
Last modified date 6/2/2006
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