Certificate of Exportability under Section 801(e) (1) of the FD&C Act (COE 801)

  • A Certificate of Exportability (COE) under Section 801(e)(1) of the FD&C Act (COE 801) is required for
    the export of medical devices that are not legally marketed in the United States and meet the requirements
    of Section 801(e)(1) of the FD&C Act.
  • Medical pieces of equipment that are not FDA approved, cleared, or have not had a request granted for
    marketing in the United States, or that are exempt from premarket notification requirements and are
    not legally marketed in the United States, can be exported under Section 801(e) (1) of the FD&C Act if
    they are destined for export only and meet the requirements of Section 801(e) (1) of the FD&C Act.
  • Although such devices do not fulfill the criteria of the FD&C Act to be marketed in the United States,
    they can be exported legally and without FDA approval if they are class I or class II devices and they are:

    • in accordance with the foreign purchaser’s specifications; not in violation of the laws of the country
      to which they are destined for export;
    • They are marked on the outside of the shipping package that they are destined for export
    • They are not marketed or offered for sale in the United States.
  • The FDA is aware that firms may wish to export certain devices while applications for approval
    under Section 510(k) of the FD&C Act are being reviewed. If a device meets two conditions, it
    may be exported without 510(k) marketing clearance:

    • The device fulfills the requirement of Section 801(e)(1);
    • and there is a realistic expectation that the device will
    • be granted 510(k) marketing clearance in the United States if reviewed by the FDA
    • because it is similar in shape, construction, and destined use to a previously approved or cleared device.

Certificate of Exportability under Section 802 of the FD&C Act (COE 802)

  • A Certificate of Exportability (COE) under Section 802 (COE 802) may be issued,
    upon request, For the export of medical devices that are not legally sold in the United States,
    Section 801(e)(1) of the FD&C Act requires the issuance of a Certificate of Exportability (COE) (COE 801).
  • Unapproved Class III and Class II devices that must meet performance requirements under Section 514 of the FD&C Act could be exported under
    Section 802 if the establishments and devices meet certain criteria.
  • To acquire a COE 802, devices must be class II or class III and fulfill the criteria of FD&C Act Section 801(e) (1). In particular, the devices must:
    • Be following the specifications of the foreign purchaser;
    • On the outside of the shipping package, indicate that it is intended for export;
    • They must not violate the laws of the country to which they are being exported, and
      Not be sold in the U.S.
  • The devices should also conform with FD&C Act Section 802(f). In particular, the devices must:
    • Meet an international standard of quality recognized by the FDA or be in substantial compliance with the Quality System regulation;
    • Other than the lack of U.S. marketing approval, the approval of a De Novo classification request, the product must not be tainted.
    • Not be the subject of a Department of Health and Human Services notice that re-importation will indeed face an imminent risk, nor face an imminent risk to the receiving country;
    • It must not be incorrectly labeled (in this case, units of measure, labeling with the language, or any other labeling sanction by the recipient country is permitted).

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FDA documents received online Regular Service

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  • Must fill the US Department of State form.

FDA documents received online Expedited Service

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  • Track your history and spending online.