Exporting Medical Devices FAQs
- Q&A on the CDRH Export Certification Application and Tracking System (CECATS)
- Q&A on Export Certificates
- When will firms be able to make requests related to export permit letters and simple notification via CECATS?
On February 10, 2015, Export Permit Letters and Simple Notifications can be submitted via CECATS.
- What is CECATS and what has recently changed?
CECATS is CDRH’s web-based application for requesting export certificates, simple notifications, and export permit letters. In the first phase, which began in November 2012, firms could begin submitting requests for a Certificate to Foreign Government electronically through CECATS.
In March 2013, CECATS was enhanced to allow submission of requests for certificates of exportability under sections 801(e)(1) and 802.
In February 2014, CDRH announced a series of CECATS enhancements. As a result of these actions CECATS users will now be able to make changes to their application prior to review, upload additional documents such as mailing labels, and copy export certificates requested under sections 801 and 802.
In September 2014, additional enhancements now allow firms to submit requests for Non-Clinical Research Use Only certificates via CECATS. In addition, contract manufacturers can be added to Certificate of Exportability in section 3, but will not appear on the certificates.
On February 10, 2015, Export Permit Letters and Simple Notifications can be submitted via CECATS.
- Is it mandatory to use CECATS in place of mailing paper requests to the FDA?
The FDA will continue to accept paper applications, but encourages applicants to use CECATS, which allows for immediate submission of the application. CECATS also features electronic notification of status update and tracking of submitted requests. Applicants, may choose to request a certificate through CECATS or mail a paper request, but should not do both. If an applicant submits a CECATS and a mail submission for the same certificate, the FDA will process and charge for both.
- How do I access CECATS and who do I contact if I have a problem accessing the system?
You can access CECATS after logging into the FDA Unified Registration and Listing Systems (FURLS). You must have a FURLS account ID and password to access this system. If you do not have one, please see the instructions on the FURLS website.
From your FURLS account to CECATS under “Account Management”, click on “Systems Update” and then choose CDRH Export Certification and Tracking System (CECATS).
Should you need assistance while in FURLS, please use the “Help Desk” link. If you require further assistance with your FURLS account, please contact Registration and Listing using the online feedback form or call 301-796-7400.
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.
- Do I have to pay more for a Certificate if I use CECATS?
No, the cost is the same for CECATS and paper applications.
- What is the format of the product list in CECATS?
CECATS provides an Excel template. This allows you to list the product name as you would like to see it on the certificate. Each row is comprised of one column and you may enter up to 90 characters in Arial font 9. If your product list consists of multiple columns, concatenation instructions are included which will allow for the appearance of multiple columns within the one column format.
- Can multiple individuals at one firm access CECATS to apply for certificates?
Yes, firms can create subaccounts for multiple individuals to use CECATS.
- If I submit a request through CECATS, will I receive the certificate instantly?
No. The FDA will review and validate the information provided and issue the certificate within 20 business days. The processing time for CECATS is significantly less than for paper requests.
- In CECATS, do I still have to provide the marketing status of my products?
Every device must have a listing on your establishment registration. The listing identifies the marketing status. If a device does not have a listing, the establishment registration must be updated.
Please contact Registration and Listing with question related to updating the registration using firstname.lastname@example.org or by calling 301-796-7400.
- 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 send your certificates to you once they are printed.
• Provide a FedEx or UPS Express or Two Day Air label with a barcode and tracking number generated by accessing the company’s website. No FEDEX Ground labels are accepted.
• The label should be self-addressed and must be a U.S. location. The FDA does not ship to foreign addresses.
• 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 2621
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.
- What do I do in response to a Return for Action notification?
When a certificate request is returned for action, all changes, edits, updates, and uploaded documents must be added to the electronic request and not e-mailed to the reviewer. The reviewer is not able to make changes to a request once it is returned for action. Enter CECATS and click “modify the application” and then “modify based on notification received”. Please note you have to make these changes within 48 hours or your request will be cancelled.
- Why is my Password (pw) not working?
• For your security, passwords (pw) expire 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.
Please contact Registration and Listing with questions related to changing the password using email@example.com or by calling 301-796-7400.
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.
- 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 & EXIT as often as possible.
- Who is required to provide an Exporter’s Certification Statement (ECS)?
ALL establishments that are listed on the export certificate must provide a signed ECS no exception.
- 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. Certificates for Foreign Governments are the most frequently requested type of certificate of export, but certificates of export for unapproved products may also be requested when exporting under Sections 801(e)(1) and 802 of the Food, Drug and Cosmetic Act. Please see the exports website for more information.
- 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.
- Is there a limit to the number of attachment pages?
Each certificate cannot exceed a total of 50 pages (including the certificate, manufacturer page and attachment pages). However, you may request as many copies as needed
- Does CDRH/FDA charge a fee for export certificates?
Yes, the FDA is authorized to charge a fee up to $175.00. CDRH charges $175 for the first certificate and $15.00 for each additional certificate, with the same list of products.
If your request (including the certificate, manufacturer page and attachment pages) exceeds 50 pages, additional fees of $175 per 50-page increment will apply.
- Can I get additional certificates and what happens if my request is over 50 pages?
Yes. Each time your total request exceeds a 50-page increment, an additional charge of $175.00 will be applied.
Example: If your request has 9 pages and you want 20 certificates your total request would be 180 pages. Since the 50-page limit was exceeded four times, you would be charged $175 x 4 for four originals and the 16 subsequent originals would be $15 each. Under this example you would be billed $700 for the initial originals + $240 for subsequent originals; the total bill for the entire request = $940.00.
- Do I send in payment with my request?
No, the FDA will invoice you. FDA generates invoices quarterly.
- What is the turnaround time for processing certificates?
Requests are processed within 20 business days from the date of receipt (excluding weekends and holidays), but the processing time for CECATS is significantly less than for paper requests.
- 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.
- Do I have to list my products on an attachment page or can I just list them on the certificate?
If you have more than three products, you will need to provide a certificate attachment page on plain white 8.5-by-11 inch paper.
CECATS automatically formats the product information. CECATS allows one product on the certificate page.
- How do I determine if my product is considered a medical device by the FDA?
Please review the medical device definition and Device-Not Device website. If you are unable to make the determination, contact the Center’s Device Determination Officers by sending an email with complete description of the product, uses, and labeling to firstname.lastname@example.org
- Can Owner Operators be listed on an export certificate?
Yes, as long as the firm is identified as an Owner Operator or Corporate Headquarters in FURLS. Please note an Owner Operator can only appear on a Certificate to Foreign Government (CFG). It cannot appear on a Certificate of Exportability. In FURLS, the Owner Operator is a facility that owns one or more registered manufacturers or distributors. It is not the Specification Developer or Legal Manufacturer.
- Does the FDA notarize or provide apostille for certificates?
As of March 2014, FDA no longer notarizes certificates. Please contact the US State Department of State for apostille and notary services. The State Department charges $8 per document for these services. You can request apostille/notarization following the instructions at the links below.
Link to the DS-4194 request form - http://www.state.gov/documents/organization/183033.pdf
- Where do I enter Contract Manufacturer/Contract Sterilizers?
All establishments involved with the manufacturing must be identified in section 2. This includes the specification developer, manufacturer, contract manufacturer, contract sterilizer, assembler, etc. If there is not enough room on form 3613, simply create an attachment page.