Exporting Medical Devices FAQs
1. What are FDA export certificates?
Firms exporting products from the U.S. are often asked by foreign customers or foreign governments to supply a certificate for products regulated by the Food and Drug Administration (FDA). An export certificate is a document prepared by the FDA containing information about a product's regulatory or marketing status in the U.S. Please see the exports website for more information.
2. Why do foreign governments want FDA export certificates?
In many cases, foreign governments seek official assurance that products exported to their countries can be marketed in the United States or meet specific U.S. regulations, such as Quality System Regulation (also known as Good Manufacturing Practice requirements). Review of an FDA export certificate may be a required part of the process to register or import a product into another country.
3. What is CECATS and what has recently changed?
CDRH Export Certification Application and Tracking System (CECATS) is CDRH’s online portal for manufacturers to request export certificates, simple notifications, and export permit letters. In November 2012, the first phase introduced the submission of requests for a Certificate to Foreign Government electronically through CECATS. CECATS is an alternative to paper submissions and 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 for the request.
In order to implement electronic submission of all export documents and continually improve the user experience, CECATS has gone through a series of enhancements:
In March 2013, CECATS was enhanced to allow manufacturers to submit requests for Certificates of Exportability under sections 801(e)(1) and 802 of Chapter VIII of the Federal Food, Drug, and Cosmetic Act.
In February 2014, CDRH made a series of enhancements which allowed users to make changes to an application prior to review, upload additional documents such as mailing labels, and clone export certificates requested under sections 801 and 802.
In September 2014, we made additional enhancements to allow manufacturers to submit requests for Non-Clinical Research Use Only certificates via CECATS.
On February 10, 2015, the FDA added the ability to request Export Permit Letters and Simple Notifications via CECATS.
In 2016, we enabled direct editing of the product list in a cloned CECATS application, as well as the ability to Save & Continue at any step.
In September 2017, enhancements included a new user interface for CECATS with updated icons and a user-friendly layout as well as the ability to enter an alternate email address and Save & Exit in section 4 of a Certificate to Foreign Government application. An alternate email address is an option to list the email address of the actual requestor to ease communication during the review process.
User feedback and suggestions are always welcome as we continue to enhance the system.
4. Can I still mail paper requests to the FDA?
Effective October 1, 2016, all paper applications received are converted to electronic applications via CECATS. The FDA will continue to accept paper applications, but encourages applicants to use CECATS, which allows for immediate submission of the application.
5. How do I access 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 press option #1.
If you need assistance on an export specific matter, please send an email to email@example.com or call 301-796-7400 and press option #3.
6. Can multiple individuals at one firm access CECATS to apply for certificates?
Yes, firms can create subaccounts for multiple individuals to use CECATS.
7. Why is my Password (pw) not working?
- For your security, FURLS requires a new password (pw) every 90 days.
- To reset, click the “I forgot my password” feature in the FDA Unified Registration/Listing System (FURLS) 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 firstname.lastname@example.org or by calling 301-796-7400, option 1.
Note: It is a quicker turn-around-time to forward an email to the registration /listing account. Also, be sure to have your account id available when attempting to access the electronic system.
8. Why does CECATS timeout after 30 minutes?
This is a feature of FURLS – the Registration and Listing system. We cannot change this in CECATS. Please SAVE & CONTINUE or SAVE & EXIT as often as possible.
9. What do I do if I am unable to access the CECATS system, or I receive an error message?
There could be many reasons why CECATS is not accessible. Please email detailed information such as the step at which the error occurred and include a screenshot, to: CDRHCECATS@fda.hhs.gov.
10. Which type of certificate or export document do I need for my device?
A Certificate to Foreign Government (CFG) can include any device that is FDA-approved or cleared and legally marketed in the U.S.
For devices that are not FDA-approved or cleared, please refer to the Exports webpage Exporting Unapproved Devices to determine the appropriate export document for your device.
The description and criteria for each document are listed under the help option when selecting the type of application in CECATS. A requestor should select the document that best fits the device being exported.
11. An establishment does not appear to have a listing for my device in section 4 of a Certificate to Foreign Government (CFG) application. What do I do?
Every establishment involved in the manufacturing of a device must have a listing for the device on their establishment registration. The errors listed in section 4 of the CFG indicate the missing manufacturing roles which must be corrected in order to be able to continue with the application. CECATS pulls the information from the Registration and Listing database. If a firm does not have a listing for a device, the registration should be updated to include the listing.
Please contact Registration and Listing with questions related to updating the registration and/or listing information using email@example.com or by calling 301-796-7400 and press option 1. Once the device listing updates have been made in Registration and Listing, you can come back to CECATS to complete the application.
12. How do I enter products 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 attachment page.
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 product list.
13. What is the format of the product list in CECATS?
CECATS provides an Excel template which allows you to list the product name(s) as you would like to see it (them) on the certificate. Each row is comprised of one column with a limit of 150 characters in Arial font 8. Do not enter products on lines 1 and 2 of the template. These lines are reserved for CECATS formatting and products entered here will not appear on the certificates.
CECATS only recognizes column A. If your product 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 attachment page.
14. 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 product attachment pages), you will need to condense the information on the product attachment pages or split the request into 2 or more applications.
15. 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.
16. Can Owner Operators be listed on an export certificate?
Yes, an Owner Operator can appear 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.
17. CECATS is asking me for a prepaid return shipping label. What does that mean?
A prepaid return shipping label is a FEDEX or UPS label for the FDA to use to send your certificates, once they are printed.
- Provide a FedEx or UPS Express or Two Day Air label with a barcode and tracking number, which can be generated by accessing the company’s website. No FEDEX Ground or FEDEX Home labels are accepted.
- Do not use US Post Office labels, handwritten labels, or typed labels.
- The label should be self-addressed to a U.S. location. The FDA does not ship to foreign addresses.
- A unique shipping label should be provided with every application.
- You may use the following for the sender’s address:
Food and Drug Administration
CDRH - Office of Compliance Export Certificates
10903 New Hampshire Avenue
Building 66, Room 3621
Silver Spring, MD 20993-0002
- Please no handwritten forms (not accepted by either carrier), address typed in a WORD document, or US Post Office labels.
18. How long will it take for FDA to process my request for a certificate?
Typically, the certificates are issued within a week of the application’s submission in CECATS. The Federal Food, Drug & Cosmetic Act (Section 801(e)(4)) requires requests to be processed within 20 government working days from the date of receipt.
19. How can I check on the status of my application?
Email updates are automatically sent to the email address that is on the application at each step of the review process. CECATS is also a tracking portal that provides real-time status updates. 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.
20. What do I do in response to a Return for Action notification?
If a certificate request is returned for action, you must make all changes, edits, updates, and document additions to the electronic request The reviewer is not able to make changes to a request once it is returned for action.
To do this, 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 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.
21. 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.
22. Is there a fee to receive an export certificate?
Yes, the FDA is authorized to charge a fee of up to $175 per certificate. CDRH charges $175 for the first certificate and $85 for each additional certificate issued from the same application with the same list of products.
Each certificate cannot exceed a total of 25 pages (including the certificate, manufacturer page and product attachment pages). However, you may request as many copies as needed.
If a certificate exceeds 25 pages (including the certificate, manufacturer page, and product attachment pages), you will need to condense the information on the product attachment pages or split the request into two or more applications.
Example: If a certificate has 9 pages and you want 20 certificates, your total application includes 180 pages. Since the 25-page limit was exceeded eight times, you would be charged $175 x 8 for eight certificates and the remaining 12 certificates would be $85 each. Under this example you would be billed ($175 x 8 certificates) $1,400 + $1,020 for subsequent originals; the total bill for the entire request would be $2,420.
23. Do I send in payment with my request?
No, the FDA will invoice you. FDA generates invoices quarterly.
24. Can I get additional certificates?
You may modify the number of certificates you request in CECATS until the application is in “Under Review” status. If the application is already in “Under Review” status, please email firstname.lastname@example.org or call 301-796-7400, and choose option 3. Once certificates have been issued for an application, you will need to submit a new application to request additional certificates.
25. 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.
26. Does the FDA notarize or provide apostille for certificates?
As of March 2014, the FDA no longer notarizes certificates. Please contact the US Department of State for apostille and certificate of authentication. The Department of State charges $8 per document for these services. You can request apostille/notarization following the instructions at the links below.
27. Can an Export Certificate to Foreign Government be obtained after an Official Action Indicated (OAI) inspection?
No. After an Official Action Indicated inspection, a domestic establishment must contact its local Inspection District.
A foreign establishment must contact the Center inspection office via email at CDRHForeignInspections@fda.hhs.gov to address deficiencies and observations listed on the Establishment Inspection Report (EIR).
28. If my firm had an inspection which 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 firm has received a letter from the District or CDRH FDA stating that the observations appear to have been adequately addressed.
Please email your CECATS application number to CDRHCECATS@fda.hhs.gov along with any FDA correspondence stating the issues have been adequately addressed. The FDA will in turn research the issue and contact your district office regarding the outcome. Based on the response from the district, we may be able to override the rejection.