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U.S. Department of Health and Human Services

Medical Devices

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How to Request Export Certificates/Permits and Submitting Simple Notification

Export communications with the FDA depend on the conditions under which the export is taking place. Communications include:

In November 2012 and March 2013, CDRH launched the first two phases of its CDRH Export Certification and Tracking System (CECATS). CECATS is a new voluntary electronic system that allows manufacturers and initial importers to request export documents online as an alternative to paper submissions. CECATS offers several benefits, including a reduction in certificate processing time, savings on material and mailing costs for paper applications, real-time validation of firm-specific data, and status updates of the request.

During the first phase of the CECATS launch, the system was available for Certificates for Foreign Governments requests. In March 2013, the second phase of CECATS was launched, making the system available for the voluntary submission of export certificate requests under sections 801(e)(1) and 802. 

CDRH expects to expand the capabilities of CECATS by late 2014 to accommodate the electronic submission of requests related to export permit letters, simple notification, and non-clinical research use only certificates. However, until that time, manufacturers must still use regular mail for these requests.

CECATS may be accessed from the FDA Unified Registration and Listing Systems (FURLS). A firm must have a FURLS account ID and password to access this system. Firms that do not have FURLS accounts should consult the “New User” section of the FURLS website for instructions. 

Export Certificates

Costs

For all export certificate requests, CDRH requires an initial fee of $175.00 for the first certificate and $15.00 for each additional certificate issued for the same product in the same letter of request. Original certificates will be provided on counterfeit-resistant paper with an embossed gold foil seal.

Up to 50 pages (to include the certificate, manufacturer page and attachment pages) may be submitted to the FDA for the same product. Each time an increment of 50 pages is exceeded, an additional charge of $175 will be applied. There are no fees associated with export permits and simple notification.

Timeframe

FDA shall issue certificates within 20 business days, after the firm shows that the product meets the applicable requirements.

Certificates for Foreign Governments

In many cases, foreign governments will seek official assurance that products exported to their countries are in compliance with U.S. law or meet specific U.S. regulations, such as current Good Manufacturing Practice (GMP) regulations.  In these cases firms may submit a Certificate for Foreign Government request to FDA.

There are two options for submitting a request for a Certificate for Foreign Government:

  • Submit your request electronically via CECATS using the CFG FDA-3613 form. If you have any questions regarding using CECATS for your request please email cdrhcecats@fda.hhs.gov or call 301-796-7400 or
  • Submit your request using the paper CFG FDA-3613 form, and mail it according to the directions on the form. If you have any questions regarding this process please email exportcert@cdrh.fda.gov or call 301-796-7400.

Certificate of Exportability under Section 801(e)(1)

Even though the FDA does not require a firm to obtain written permission prior to export under section 801(e)(1), a foreign purchaser may request proof of compliance with U.S. law prior to export. The FDA implemented a certification process referred to as a Certificate of Exportability (COE) to facilitate export of unapproved medical devices under section 801(e)(1). Exporters applying for a COE are required to sign a statement indicating that they meet the criteria of 801(e)(1). False statements are violations of United States Code Title 18, Chapter 47, Section 1001.

  • Submit your request electronically via CECATS using the FDA-3613a form. If you have any questions regarding using CECATS for your request, please email cdrhcecats@fda.hhs.gov or call 301-796-7400 or
  • Submit your request using the paper FDA-3613a, and mail it according to the directions on the form. If you have any questions regarding this process please email exportcert@cdrh.fda.gov or call 301-796-7400.

Certificate of Exportability under Section 802

Even though the 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. The FDA will provide a 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. False statementsare violations of United States Code Title 18, Chapter 47, Section 1001.

There are two options for submitting a request for a Certificate of Exportability under section 802:

  • Submit your request electronically via CECATS using the FDA-3613a form. If you have any questions regarding using CECATS for your request, please email cdrhcecats@fda.hhs.gov or call 301-796-7400 or
  • Submit your request using the paper FDA-3613a, and mail it according to the directions on the form. If you have any questions regarding this process, please email exportcert@cdrh.fda.gov or call 301-796-7400.

How to Request Non-Clinical Research Use Only Certificates

While FDA permission is not required when exporting a non-clinical research use only product, the FDA will supply firms with a certificate upon request. The Non-Clinical Research Use Only Certificate is for the export of non-clinical research use only products, materials, or components not intended for human use, which may be marketed in, and legally exported from, the United States under the Federal, Food, Drug, and Cosmetic Act.

Until CECATS is fully established, firms must submit their requests for non-clinical research use only certificates using the paper CFG FDA-3613c form, which should be completed and mailed according to the directions on the form. Questions regarding this process should be directed to exportcert@cdrh.fda.gov or 301-796-7400.

Export Permit Letter via Section 801(e)(2)

To obtain an Export Permit Letter, which affirms the FDA's approval to export devices in accordance with section 801(e)(2) of the FD&C Act, a request should include the following information:

  • 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 statement indicating that the requestor conducted a search of the Medical Literature Analysis and Retrieval System database (see instructions below) and a summary of the search results, as well as a summary of safety data to demonstrate that export of the device will not endanger the public health and safety, or documentation of exemption from this requirement (see below), 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 that:
    • 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.

If the manufacturer is exporting a device with a “CE” mark to a country within the European Economic Area, FDA will accept documentation of receipt of the CE mark in lieu of a letter from the foreign government approving importation.

Searching the U.S. National Library of Medicine (NLM)Databases

There are two circumstances in which FDA does not request a search of the NLM databases and submission of safety data with an export request:

  • The device has an FDA-approved Investigational Device Exemption 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 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.

In all other cases, the FDA requires that the requester conduct searches of the NLM databases and provide safety data. As noted above, FDA requires a summary of search results for most requests under section 801(e)(2).

The FDA does not have an estimated timeframe for responding to export permit requests.

Request for an Export Permit Letter to should be mailed to:

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

Questions regarding this process should be sent to: exportcert@cdrh.fda.gov

Submitting Simple Notification to the FDA for Exporting via Section 802

While the FDA does not require a firm to obtain written permission prior to export under section 802, firms exporting a device under section 802 must provide written notification to the 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 product if the export is to a “not listed” country (non-Tier 1 country).

If the export is intended for a “listed” Tier 1 country, then the notification may, but is not required to, identify the importing country. Or it may state that export is to a Tier 1 country without identifying the listed country.

Please mail or email the notification to:

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
Email: cdrhcecats@fda.hhs.gov

By late 2014, CDRH is scheduled to expand CECATS. Once this occurs, firms will be able to submit simple notifications via CECATS.  Until this system is fully operational, continue to mail simple notification requests to the address listed above.