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 (U.S.). Please see the Exporting Medical Devices Device Advice webpage for more information.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. Which type of certificate or export document do I need for my device?
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 device being exported.
8. In section 4 of a Certificate to Foreign Government (CFG) application, 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 on 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 and/or 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.
9. How do I enter product information into my CECATS application?
For a Certificate to Foreign Government (CFG) application, the product information to be displayed on the certificate can be added for each medical device in either the proper name block of section 4 or a product list can be uploaded in section 7. The CECATS product templates for each application type can be found at Certificate Attachments Device Advice webpage.
CECATS will automatically format the product and manufacturer information based on selections made in section 7. Additionally, once a template has been uploaded, the product list section must be restarted in order to upload a new device list.
10. 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.
11. 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.
12. Does it matter which establishment is identified as the Primary Facility?
Yes. The primary facility must be the firm the requestor represents. The primary facility’s name is entered onto the Exporter’s Certification Statement (ECS) which is signed at the end of the application by the requestor.
13. Can an Owner/Operator be listed on an export certificate?
An Owner/Operator can appear only on a Certificate to Foreign Government (CFG). CECATS will retrieve the Owner/Operator name and address based on the primary facility’s registration in FURLS.
14. How long will it take for FDA to process a request for a certificate?
Typically, the certificates are issued within a week of the receipt of the submission in CECATS. Section 801(e)(4) of the Federal Food, Drug & Cosmetic Act requires requests to be processed within 20 government working days from the date of receipt.
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 the 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?
No, 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 to Foreign Government?
Yes, a new export certificate request may be submitted once the FDA determines that the inspectional observations appear to have been adequately addressed.
20. Can a certificate to foreign government be obtained by a foreign establishment for a device that may have marketing authorization in the United States and that is manufactured in a foreign country and shipped to another foreign country?
On March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security (CARES) Act into law. Section 3856(a) of the CARES Act amended section 801(e)(4)(E)(iii) of the Federal Food, Drug, and Cosmetics Act, and governs the issuance of certificates to foreign governments. We are currently working on the implementation of this statutory change and will provide updates when they become available.