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What are the procedures for exporting an unapproved device?
Exporting Medical Devices Via Section 801(e)(1) Requirements A medical device which would be considered to be adulterated or misbranded, may be exported under Section 801(e)(1) of the FD&C Act provided the device is intended solely for export. Although such a device would not meet the requirements of the FD&C Act to be sold domestically for commercial distribution, it may be exported legally and without FDA permission in accord with Section 801(e)(1) provided the device is: in accordance with the specifications of the foreign purchaser; not in conflict with the laws of the country to which it is intended for export; labeled on the outside of the shipping package that it is intended for export; and not sold or offered for sale in domestic commerce. Once an adulterated or misbranded device is sold or offered for sale in commercial distribution in the U.S., it may not be exported under Section 801(e)(1) as an alternative to bringing the device into compliance with the requirements of the Act. Devices that have been imported are considered to be in domestic commerce. Unapproved Devices due to lack of 510(k) marketing clearance The FDA is aware that in certain instances there may be devices which firms may wish to manufacture solely for export, or which they may wish to export during the interim period while their Premarket Notification 510(k) is under review. FDA allows the export of a device that does not have a 510(k) marketing clearance without prior FDA clearance if it meets two conditions: the device meets the requirements of 801(e)(1) listed above, and it is reasonably believed that the device could obtain 510(k) marketing clearance in the U.S. if reviewed by FDA. This includes only devices which are similar in design, construction, and intended use to class I or class II devices or which the firm reasonably believes would be "substantially equivalent" to class I or class II devices. Devices which would not be included under this consideration are: Preenactment class III devices for which FDA has called for the submission of a PMA Postenactment class III devices, i.e. placed on the market after May 28, 1976, or Devices evaluated by a firm and found to be not substantially equivalent to a 510(k)'d device. Recordkeeping Requirements Persons exporting an article under section 801(e)(1) of the act or an article otherwise subject to section 801(e)(1) of the act must maintain records demonstrating that the product meets the requirements of section 801(e)(1) of the act. These records must be maintained for the same period of time as required for records subject to good manufacturing practice or quality systems regulations applicable to the product. That is, all records must be retained for a period of time equivalent to the design and expected life of the device, but in no case less than two years from the date of release for commercial distribution by the manufacturer (21 CFR 820.180). The records must be made available to the Food and Drug Administration (FDA), upon request, during an inspection for review and copying by FDA. The records required to be maintained under 21 CFR 1.101 include the following: Records demonstrating that the product meets the foreign purchaser's specifications. The records must contain sufficient information to match the foreign purchaser's specifications to a particular export; Records demonstrating that the product does not conflict with the laws of the importing country. This may consist of either a letter from an appropriate foreign government agency, department, or other authorized body stating that the product has marketing approval from the foreign government or does not conflict with that country's laws, OR a notarized certification by a responsible company official in the United States that the product does not conflict with the laws of the importing country and that includes a statement acknowledging that he or she is subject to the provisions of making false statements to the government under 18 U.S.C. 1001; Records demonstrating that the product is labeled on the outside of the shipping package that it is intended for export: This may consist of copies of any labels or labeling statements, such as ``For export only,'' that are placed on the shipping packages or, if the exported product does not have a shipping package or container, on shipping invoices or other documents accompanying the exported product; and Records demonstrating that the product is not sold or offered for sale in the United States: This may consist of production and shipping records for the exported product and promotional materials. Certificate of Exportability The FDA implemented a new certification process referred to as a Certificate of Exportability (COE) to facilitate export of a medical device under 801(e)(1). Exporters applying for a COE are required to sign a statement indicating that they meet the four criteria of 801(e)(1) as detailed above. False statements are violations of United States Code Title 18, Chapter 47, Section 1001. Penalties for a false statement include up to $250,000 in fines and up to five years imprisonment. CDRH requires an initial fee of $175.00 per certificate and $15.00 per certificate for additional certificate(s) issued for the same product(s) in the same letter of request. Original certificates will be provided on special counterfeit resistant paper with an embossed gold foil seal. CDRH should to issue the certification within 20 days upon the firm's showing that the product meets the applicable requirements. You should submit your request for a COE on form FDA-3613a, Supplementary Information Certificate of Exportability Requests. Questions regarding the COE should be directed to the Office of Compliance, Export Certificate Team, at 240-276-0132. (exportcert@cdrh.fda.gov) Exporting Medical Devices via Section 802 Requirements Unapproved Class III devices and devices required to meet a performance standard under section 514 of the FD&C Act may be exported under section 802 if the firm and the device meets certain criteria. These devices include investigational devices, unapproved devices which would not be able to obtain a PMA (or for which a PMA has not been approved), and banned devices. (At the present time synthetic hair fibers intended for implant is the only banned medical device.) In order to qualify for export under 802, devices must meet the requirements under 801(e)(1) and pass the restrictions set forth in 802(f). That is, the devices must: meet the requirements of section 801(e)(1). The device is in accordance with the specifications of the foreign purchaser; not in conflict with the laws of the country to which it is intended for export; labeled on the outside of the shipping package that it is intended for export; and not sold or offered for sale in domestic commerce. substantially meet Quality Systems Regulation (also known as Good Manufacturing Practices) or an international quality standard recognized by FDA (currently, none are recognized), not be adulterated other than by the lack of marketing approval, not be the subject of a notice by Department of Health and Human Services that re-importation would pose an imminent hazard, nor pose an imminent hazard to the receiving country, and not be mislabeled other than by possessing the language, units of measure, or any other labeling authorized by the recipient country. In addition, the labeling must comply with the requirements and conditions of use in the listed country which gave marketing authorization, and must be promoted in accordance with its labeling. Currently, electrode lead wires and patient cables (21 CFR 898) are the only devices with an FDA performance standard under section 514 of the FD&C Act. In addition to the requirements above, the device must comply with the laws of the receiving country and have valid marketing authorization by the appropriate authority in a listed (Tier 1) country. This means that a firm whose device has received marketing authorization in any of the Tier 1 countries can export that device to any country in the world as long as the device meets applicable requirements of the FD&C Act and the marketing authorization by the Tier 1 country is acceptable to the appropriate authorities in the importing country. Some South American countries, for example, now permit marketing of any medical device with a CE mark. If the appropriate authorities of a non-Tier 1 country will not accept the marketing authorization of a Tier 1 country, you can obtain an export permit under section 801(e)(2). The complete requirements of Section 802 can be found in the FD&C Act and a detailed discussion is contained in the Regulatory Procedures Manual. The intent of FDERA was to expedite the export of products which do not comply with U.S. law, but which are in compliance with the laws of foreign countries. The primary advantage to exporting under section 802 instead of 801(e)(2) is that approval from FDA, i.e. submitting a request for and obtaining an Export Permit is not necessary in order to export. The exporter must submit a "Simple Notification" as per section 802(g) to FDA when the firm begins to export. No approval from FDA is required. If the firm or device does not comply with the above criteria, the device cannot be exported under section 802. However, the device may qualify for exportation under section 801(e)(2). Listed (Tier 1) Countries The listed (or "Tier 1") countries are: Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, a member of the European Union (United Kingdom, Spain, Ireland, Denmark, Greece, Belgium, Portugal, Germany, France, Italy, Luxembourg, Netherlands, Sweden, Finland, and Austria), or the European Economic Area (includes the European Union countries and Norway, Iceland, and Liechtenstein). As of May 2004, the European Union also includes Cyprus, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia, and Slovenia. Simple Notification Persons exporting a device under section 802 of the act must provide written notification to FDA. The notification must identify: The product's trade name; The type of device; The product's model number; and The country that is to receive the exported article if the export is to a country not listed (non tier 1 country). The notification may, but is not required to, identify the listed (tier 1) countries or may state that the export is intended for a listed (tier 1) country without identifying the listed country. The notification shall be sent to the following address: Food and Drug Administration CDRH - Office of Compliance Export Certificates 10903 New Hampshire Avenue Building 66 Room 2621 Silver Spring, MD 20993-0002 Telephone number: 301-796-7400 exportcert@cdrh.fda.gov Devices that are regulated by the Center for Biologics Evaluation and Research should mail the simple notification to the following address: Food and Drug Administration Center for Biologics Evaluation and Research (CBER) Office of Compliance and Biologics Quality Division of Case Management (HFM- 610) 1401 Rockville Pike, rm. 200N Rockville, MD 20852-1448 List of medical devices reviewed by CBER Recordkeeping Requirements Any person exporting a product under any provision of section 802 of the act shall maintain records [section 802(g)] of all devices exported and the countries to which the products were exported. In addition to the requirements in 801(e)(1) noted above, such records include, but are not limited to, the following: The product's trade name;· The type of device; The product's model number; The consignee's name and address; and The date on which the product was exported and the quantity of product exported. These records shall be kept at the site from which the products were exported or manufactured, and be maintained for the same period of time as required for records subject to good manufacturing practice or quality systems regulations applicable to the product. That is, all records must be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer (21 CFR 820.180). The records shall be made available to FDA, upon request, during an inspection for review and copying by FDA. Additional Provisions under 802 Additional situations where export permission is automatically granted under section 802: Devices exported for investigational use- Medical devices may be exported under an Investigational Device Exemption (IDE), e.g. instances where clinical investigations are being conducted abroad. As per section 802(c), the export of a medical device for investigational use in any Tier 1 country may be exported in accordance with the laws of that country and is exempt from regulation under the IDE statutory requirements of the FD&C Act [section 520(g)]. Additional guidance can be found in Exporting for Investigational Use below and as well as Section 802 of the FD&C Act. Exported devices intended for further processing - As per section 802(d), a medical device intended for further processing pending expected marketing authorization from a listed (tier 1) country may be exported for use in that country. The fundamental concept is that the device is being exported in anticipation of marketing approval. Additional guidance can be found in Exporting for Marketing or in Anticipation of Foreign Marketing Approval below as well as Section 802 of the FD&C Act. Devices intended for treatment of non - U.S. diseases - As per section 802(e)(1) a medical device intended for the diagnosis, treatment, or prevention of a tropical disease or another disease not prevalent in the U.S. which does not otherwise meet 802 criteria, may be exported with an FDA approved application for export if FDA finds that the device does not present: unreasonable risk the benefits outweigh the risks, and the risks of using available alternatives was considered. Additional guidance can be found in Regulatory Procedures Manual as well as Section 802 of the FD&C Act. Certificate of Exportability Even though FDA does not require a firm to obtain written permission prior to export under section 802, a foreign purchaser may request proof of compliance with U.S. law prior to export. FDA will provide a Certificate of Exportability (COE) to the exporter under section 802 to facilitate export of a medical device. Exporters applying for a COE are required to sign a statement indicating that they are exporting legally under the provisions of section 802 as detailed above. False statements are violations of United States Code Title 18, Chapter 47, Section 1001. Penalties for a false statement include up to $250,000 in fines and up to five years imprisonment. CDRH requires an initial fee of $175.00 per certificate and $15.00 per certificate for additional certificate(s) issued for the same product(s) in the same letter of request. Original certificates will be provided on special counterfeit resistant paper with an embossed gold foil seal. CDRH should to issue the certification within 20 days upon the firm's showing that the product meets the applicable requirements. You should submit your request for a COE on form FDA-3613a, Supplementary Information Certificate of Exportability Requests. Questions regarding the COE should be directed to the Office of Compliance, Export Certificate Team, at 240-276-0132. (exportcert@cdrh.fda.gov) Requirements Class III investigational devices, banned devices, and unapproved devices for which a PMA has not been submitted to CDRH (or for which a PMA has not been approved) that do not meet the criteria under section 802 may qualify for export under section 801(e)(2). The types of devices subject to section 801(e)(2) are: a device that does not comply with section 514 (performance standards) of the FD&C Act ; a device that requires an approved Premarket Approval but does not have one; a device undergoing clinical investigation ; and a device that is banned from the U.S. market under Section 516 of the FD&C Act Currently, electrode lead wires and patient cables are the only devices with an FDA performance standard (21 CFR 898) and synthetic hair fibers intended for implant is the only banned medical device (21 CFR 895). Export under section 801(e)(2) is required when exporting an unapproved Class III device in which: the importing country will not accept the marketing authorization of a listed (Tier 1) country as described in Section 802; or the intent is to conduct clinical investigations in a country not listed in Section 802; or the device is not manufactured in substantial conformance with the Quality System (GMPs). The device must meet the following criteria to be exported: The device must meet the requirements under Section 801(e)(1) of the FD&C Act, that is, the device is in accordance with the specifications of the foreign purchaser; not in conflict with the laws of the country to which it is intended for export; labeled on the outside of the shipping package that it is intended for export; and not sold or offered for sale in domestic commerce. A review by FDA must determine that the exportation of the device is not contrary to public health and safety and The device has the approval of the country to which it is intended for export. Export Permit To obtain FDA's approval to export these devices in accord with Section 801(e)(2) of the FD&C Act, 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 not objected to. a statement that the requestor conducted a search of the Medlars database and a summary of the search results, and a summary of safety data to demonstrate that export of the device will not be contrary to the public health and safety. 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. Procedures recommend that the requester conduct a search of the Medical Literature Analysis and Retrieval System (MEDLARS) database and provide safety data. MEDLARS is the computerized system of databases and databanks offered by the National Library of Medicine (NLM). There are two circumstances in which FDA does not request a search of the MEDLARS database and 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 two Institutional Review Boards (IRBs) 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. Submit your request for an Export Permit to the following address: Food and Drug Administration CDRH - Office of Compliance Export Certificates 10903 New Hampshire Avenue Building 66 Room 2621 Silver Spring, MD 20993-0002 Telephone number: 301-796-7400 exportcert@cdrh.fda.gov
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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