A Certificate of Exportability (COE) under Section 801(e)(1) of the FD&C Act (COE 801) is for the export of medical devices that may not be legally marketed in the U.S. and that they meet the requirements of Section 801(e)(1) of the FD&C Act.
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Medical devices that are not FDA approved, cleared, or have not had a De Novo request granted for marketing in the U.S. or that are exempt from pre-market notification requirements and not authorized to be legally marketed in the U.S., can be exported under Section 801(e)(1) of the FD&C Act, provided that they are intended for export only and meet the requirements of Section 801(e)(1) of the FD&C Act. Although such devices do not meet the requirements of the FD&C Act to be marketed in the U.S., they can be exported legally and without FDA permission per Section 801(e)(1) of the FD&C Act if they are class I devices or class II devices and they are:
The FDA is aware that there may be certain devices that firms wish to export while applications for clearance under Section 510(k) of the FD&C Act are under FDA review. As indicated in FDA’s guidance document, Exports Under the FDA Export Reform and Enhancement Act of 1996, a device may be exported without 510(k) marketing clearance if it meets two conditions:
The device meets the requirements of Section 801(e)(1); and
There is reasonable expectation that the device could obtain 510(k) marketing clearance in the U.S. if reviewed by the FDA because it is similar in design, construction, and intended use to an already approved or cleared device.
A Certificate of Exportability (COE) under Section 802 (COE 802) may be issued, upon request, for the export of medical devices that may not be legally marketed in the U.S. and that meet the requirements of Section 802 of the FD&C Act.
Devices intended for treatment of diseases not prevalent in the U.S. - As per Section 802(e)(1) of the FD&C Act, a medical device intended for the diagnosis, treatment, or prevention of a tropical or other type of disease not prevalent in the U.S., which does not otherwise meet the criteria of section 802 of the FD&C Act, may be exported with an FDA approved application for export if the FDA finds that:
The device does not expose patients to an unreasonable risk of illness or injury;
The benefits outweigh the risks of illness or injury from its use; and
The probable risks and benefits of using available device alternatives were considered.
For more legal information about the Certificate of Exportability please refer to the general guidelines set by FDA.
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