Medical Devices

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 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 compared to 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 Certificate to Foreign Government requests. In March 2013, the second phase of CECATS was launched, making the system available for the submission of export certificate requests under sections 801(e)(1) and 802. 

In February and May 2014, CDRH made a series of enhancements to CECATS that responded to user feedback.

In September 2014, CECATS was enhanced with additional capabilities including the ability to apply for a Non-Clinical Research Use Only certificate and to add a contract manufacturer or contract sterilizer to requests for a Certificate of Exportability.

On February 10, 2015, Export Permit Letters and Simple Notifications can be submitted via CECATS.

CDRH will hold an online training session about CECATS Export Permit Letters and Simple Notification submission via Adobe Connect on February 10th, 2015, from 2:00 – 3:30 p.m. (EST). Advanced registration is not necessary, but we encourage participants to test their connection prior to the webinar. Participants will not be able to enter the meeting until the host has logged in on the day of the event.

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.

A single certificate cannot exceed 50 pages (including the certificate, manufacturer page and attachment pages). There is no limit to the number of copies that can be requested.

However, 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.

Exporter’s Certification Statement

All establishments that are to be listed on the final certificates must provide a signed Exporter’s Certification Statement. The document is found in the appropriate paper request packet. If applying electronically, these document(s) are uploaded in section 9. No changes to the body of text are permitted. Firms may indicate their role, such as Contract Manufacturer, beside the firm name.

Shipping Label

Please provide a prepaid UPS or FEDEX label for the FDA to send your certificates to you once they are printed. No FEDEX Ground labels are accepted. The label should be self-addressed and must be a U.S. location. If applying electronically, you will be asked to upload this document in section 9.
 

Certificate to Foreign Government

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 Quality System Regulations (QSR) (also known as Good Manufacturing Practice requirements). In these cases, firms may submit a Certificate to Foreign Government request to FDA.

There are two options for submitting a request for a Certificate to 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 statements are 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.

Non-Clinical Research Use Only Certificate

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.

There are two options for submitting a request for a Non-Clinical Research Use Only Certificate:

  • Submit your request electronically via CECATS9 using the FDA-3613c 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-3613c10, 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.
     

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.

There are two options for submitting a request for an Export Permit Letter under section 801(e)(2):

  • Submit your request electronically via CECATS after February 10, 2015. 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 via mail to the address below. If you have any questions regarding this process please email exportcert@cdrh.fda.gov  or call 301-796-7400.

    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

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.

There are two options for submitting a Simple Notification under section 802:

  • Submit your simple notification electronically via CECATS after February 10, 2015. 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 simple notification via mail to the address below. If you have any questions regarding this process please email exportcert@cdrh.fda.gov or call 301-796-7400.

    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
     

Page Last Updated: 01/29/2015
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