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 permits, simple notification, and non-clinical research use only certificates via CECATS?
CDRH plans to work throughout 2014 to expand the capabilities of CECATS. We expect that another CECATS related announcement will be made by the end of 2014.
- 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 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.
- 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 and notification of request receipt via e-mail, as well as status updates via the Internet.
Applicants may choose to request a certificate through CECATS or mail a paper request, but should not do not 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 theFDA 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.
Once in FURLS, you can link your FURLS account to CECATS by clicking on “Systems Update” under “Account Management” in FURLS.
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 firstname.lastname@example.org or call 301-796-7400 and press option #3.
- Do I have to pay more for a Certificate if I use CECATS?
No, there is no additional fee for using CECATS. The original Certificate is $175 and additional copies are $15 per copy. Up to 50 pages (including the certificate, manufacturer page, and attachment pages) may be submitted for the same product. Each time an increment of 50 pages is exceeded, an additional fee of $175 will be charged.
- Can I still use our current format for product listings?
Yes. CECATS also has an option to upload a product list from a Microsoft Excel spreadsheet. This will allow you to list the product name as you would like to see it on the certificate.
- 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. We anticipate that processing time will be reduced significantly for requests submitted through CECATS.
- Will I be able to electronically submit a return slip for mailing processed certificates?
Yes. You will be able to upload a mailing return slip for UPS or FedEX.
- Do I still have to provide the marketing status of my products?
You will be asked to provide the registration number for facilities on your request. The system will display all the products listed for that registration number, and you will be able to select the products that you would like to include on your certificate.
Only products included in the listing from the FURLS account may be included on your certificate.
- 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 may also be requested when exporting under Sections 801(e)(1) and 802 of the Food, Drug and Cosmetic Act. Please see theexports 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 current Good Manufacturing Practice (GMP) regulations. Review of an FDA export certificate may be a required part of the process to register or import a product into another country.
- 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 bill you 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 we expect that the use of CECATS will help to expedite fulfillment of these 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. This page will be generated for you by the CECATS system.
- Does the FDA provide apostilles for FDA issued export-related documents?
No, the FDA does not provide this type of documentation. A Certificate to Foreign Government (or other export document) is the official document from the FDA. For more information on apostille requirements, please refer to the State Department website.
- How do I determine if my product is considered a medical device by the FDA?
Please review themedical 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 email@example.com
- 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.