Exporting Medical Devices Frequently Asked Questions (FAQs)
1. What are FDA export certificates?
An export certificate is a document prepared by the Food and Drug Administration (FDA) containing information about a product's regulatory or marketing status in the United States. An export certificate may be issued for medical devices being exported from the United States and includes a Certificate to Foreign Government, Certificate of Exportability and Non-Clinical Research Use Only certificate. Please see the Exporting Medical Devices Device Advice webpage for more information.
2. What is a Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE)?
A CFG-NE is a document prepared by the FDA that may be issued for medical devices that are manufactured outside of the United States (OUS) and are shipped to another OUS country. Please see Devices not Exported from the United States for more information.
3. How do I access CDRH Export Certification Application and Tracking System (CECATS) and who do I contact if I have a problem accessing the system?
You can access CECATS through the FDA Industry Systems page. Enter your FURLS Account ID and password, click the "I understand" radio-button, and then Login.
If you do not have a FURLS account ID and password, please contact the person that maintains the establishment registration for your firm. Please refer to Accessing CECATS and Creating a Subaccount for detailed instructions.
If you require assistance with your FURLS account, please contact Registration and Listing using the online feedback form or call 301-796-7400 and select option 1.
If you need assistance on an export specific matter, please send an email to firstname.lastname@example.org or call 301-796-7400 and select option 3.
4. Can multiple individuals at one firm access CECATS to apply for certificates?
Yes, firms can create subaccounts for multiple individuals to use CECATS. Please refer to Accessing CECATS and Creating a Subaccount for detailed instructions.
5. Why is my Password not working?
- For your security, FURLS requires a new password every 90 days.
- To reset, click the "I forgot my password" feature and follow the prompts.
- A temporary password will be emailed which you will be prompted to change after logging in.
Please contact Registration and Listing with questions related to changing the password using email@example.com or by calling 301-796-7400 and selecting option 1.
6. Why does CECATS timeout after 30 minutes?
Timing out is a security feature that cannot be changed. Please SAVE & CONTINUE or SAVE & EXIT as often as possible.
7. What do I do if I receive an error message?
There are various types of error messages. Please email detailed information, such as the step at which the error occurred and include a screenshot, to CDRHCECATS@fda.hhs.gov.
8. Which type of certificate or export document do I need for my device?
For devices being exported from the United States, please review the "Types of Certificates" and "Other Export Documents" Device Advice webpages for a description of export documents issued.
For devices not exported from the United States, please review Devices not Exported from the United States.
When selecting the type of application in CECATS, the description and criteria for each document are listed under the help option designated with a question mark symbol. A requestor should select the document that best fits the marketing status and location the device is being shipped from.
9. In section 4 of a Certificate to Foreign Government (CFG) application, or section 3 of the Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE), the establishment does not appear to have a listing for my device. What do I do?
Every establishment involved in the manufacturing of a device must have a listing for the device in their establishment registration. CECATS retrieves the listings displayed from the Registration and Listing database. If an establishment does not have a listing for a device, it should update its registration by either re-activating an existing listing or creating a new listing.
Please contact Registration and Listing with questions related to updating the registration listing information using firstname.lastname@example.org or by calling 301-796-7400 and selecting option 1.
Once the device listing updates have been made in Registration and Listing, you can come back to CECATS to complete the application.
10. How do I enter product information into my CECATS application?
CECATS product list templates for each application type can be found at Certificate Attachments Device Advice webpage. When in CECATS, click on the question mark in the upper right corner to access the instructions specific to the application and section you are completing.
CECATS will automatically format the product and manufacturer information based on selections made in the application. Additionally, once a template has been uploaded, the product list section must be restarted in order to upload a new product list.
11. What is the format of the product list in CECATS?
CECATS provides an Excel template that allows you to list the device name(s) as you would like to see it on the certificate. Each row is comprised of one column with a limit of 150 characters in Arial font 8. Do not enter devices on lines 1 and 2 of the template. These lines are reserved for CECATS formatting and devices entered here will not appear on the certificates.
CECATS only recognizes column A. If your device list consists of multiple columns, Excel's concatenation function will allow for the appearance of multiple columns within the one column format. All templates as well as concatenation instructions are provided on the Certificate Attachments Device Advice webpage.
12. Is there a limit to the number of attachment pages? What happens if my request is over 25 pages?
Each certificate cannot exceed a total of 25 pages (including the certificate, manufacturer page and attachment pages). However, you may request as many copies as needed.
If a certificate exceeds 25 pages (including the certificate, manufacturer page, and device attachment pages), you will need to condense the information on the device attachment pages or split the request into 2 or more applications.
13. Can an Owner or Operator be listed on a certificate?
An Owner or Operator can appear on a Certificate to Foreign Government (CFG) or a Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE). CECATS will retrieve the Owner or Operator name and address based on the primary facility (identified during the application process) registration in FURLS. The primary facility is the establishment the requestor represents.
14. How long will it take for the FDA to process a request for a certificate?
Section 801(e)(4)(B) of the Federal Food, Drug & Cosmetic Act provides that if requests are processed within 20 working days from the date of receipt, the FDA may charge a fee.
15. How can I check on the status of my application?
To check on the status of an application, please select "Search Application" and then enter the application number. The current status will be displayed. If the application number is not known, simply select "Enter New Application" and the status of all previously submitted applications will be displayed on the screen.
16. What do I do in response to a Return for Action notification?
If a certificate request is returned for action, please address the reviewer's comments and modify the application as needed.
To make changes, enter CECATS, click "modify application," enter the application number, and edit the appropriate sections. Please note that requested changes must be made within 48 hours of receiving the Return for Action Notification or the application status will automatically change to "incomplete." The application can no longer be modified once it is in "incomplete" status. You will need to clone the application, modify accordingly, review the changes, and resubmit. CDRH is not able to make changes to a request once it is returned for action.
17. Why can't changes be made to an application that is marked "Incomplete"?
CECATS has system limitations that only allow the requestor 48 hours to make corrections before the status is automatically changed to "incomplete." After 48 hours, the application can no longer be modified, but requestors can clone the application, update as necessary, and submit.
18. After my initial certificate request, can I obtain additional certificates by contacting the analyst who issued my certificates?
You must submit a new request.
19. If my firm had an inspection that was classified as OAI, and I have addressed all the concerns in the inspection, can I apply for a certificate?
Yes, a new certificate request may be submitted once the FDA determines that the inspectional observations appear to have been adequately addressed.
20. Can a foreign establishment obtain a Certificate to Foreign Government for a device that is authorized to be marketed in the United States and that is manufactured in a foreign country and shipped to another foreign country?
For a device manufactured outside of the United States (OUS) and shipped to another OUS country, you may request a Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE).
The CFG-NE certifies to information regarding a device that is manufactured OUS, authorized to be marketed in the United States, and imported or offered for import into the United States. This device, and the establishment that produces it, are subject to the FDA’s jurisdiction under the FD&C Act. The FDA does not have authority over devices that are not imported or offered for import into the United States. This lack of jurisdiction means that the FDA has limited information, as the agency generally would not inspect such a device even when inspecting the establishment in which it is manufactured. If the same OUS manufacturer produces a device that is shipped to another foreign country and is not imported or offered for import into the United States, the FDA likely does not have jurisdiction over such device and cannot certify its conformance with the FD&C Act.