Devices Not Exported from the United States
Update: January 2, 2024
Effective January 2, 2024, export documents for medical device products that CDRH regulates will be issued to requestors electronically as downloadable PDFs through the CDRH Export Certification Application and Tracking System (CECATS).
Certificates may be authenticated by foreign governments and others using the FURLS Export Certificate Validator (FECV) for the time they are in effect. The FECV can be accessed using the internet address or Quick Response (QR) code displayed at the bottom of each certificate.
Read Electronic Export Documents – Letter to Industry.
On this page:
- Overview
- Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE)
- How to Request a CFG-NE
- Paper Application or Notification
- Fees
- FDA Unified Registration and Listing Systems (FURLS) Export Certificate Validator (FECV)
- CDRH Export Certificate Validation (CECV)
- Resources
Overview
Section 3304 of the Consolidated Appropriations Act, 2023 signed into law on December 29, 2022, amends section 801(e)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), which directs the FDA to provide certification for devices that are not exported from the United States (U.S.) if certain conditions are met. Manufacturers of devices not exported from the U.S., as described in section 801(e)(4)(F)(1) of the FD&C Act, may not receive export certificates (such as CFGs), but may request a Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE).
Certificate to Foreign Government for Device Not Exported from the United States
A Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE) may be issued for medical devices manufactured outside of the U.S. that are cleared, approved, or are not required to submit a premarket report, and are shipped from outside of the U.S. to another foreign country provided certain conditions are met.
Establishments requesting a CFG-NE should provide the following information on Form 3613g, including certifying that:
- Each device that appears on the certificate is manufactured by a device establishment located outside of the United States;
- Each establishment that appears on the certificate is currently registered under section 510 of the FD&C Act;
- Each establishment has listed each of the medical devices that appear on the certificate, as required by section 510(j) of the Act and 21 CFR Part 807;
- Each device identified herein is authorized to be marketed within the U.S. and:
- is the subject of a premarket notification under section 510(k) of the FD&C Act; or
- is the subject of an approved premarket approval application (PMA) under section 515(d) of the FD&C Act; or
- is the subject of an approved humanitarian device exemption under section 520(m) of the FD&C Act; or
- has been granted De Novo classification request under section 513(f)(2) of the FD&C Act; or
- was in commercial distribution before May 28,1976; or
- is not required to submit a premarket report pursuant to subsection (l) or (m) of section 510 of the FD&C Act;
- Each device is imported or offered for import into the U.S.;
- Each device identified is not subject of an open import alert, recall, seizure, injunction, or the subject of any other open enforcement action initiated by the FDA;
- Manufacturers, contract manufacturers, and contract sterilizers involved in the manufacturing process, if applicable, have been identified;
- The requesting establishment and all establishments involved in the manufacturing process are operating in substantial compliance with the current Good Manufacturing Practices Requirements (Section 520(f) of the FD&C Act) for the identified device.
How to Request a CFG-NE
The CDRH Export Certification Application and Tracking System (CECATS) is a web-based application system which can be used for requesting a CFG-NE. This system offers several benefits, including a reduction in certificate processing time, real-time validation of firm specific data, and status updates of the request. Using CECATS, users can make changes to an application prior to the FDA review, upload additional documents such as the product list, clone (auto populate) previously submitted application information for future requests using the "clone" icon, and download or print issued certificates.
To submit a request using CECATS:
- Sign into your CECATS account using your account ID and password. CECATS may be accessed after logging into the FDA Unified Registration and Listing Systems (FURLS) using the establishment's FURLS account ID and password. See Accessing CECATS and Creating a Subaccount for additional instructions on how to access the system or set up a subaccount.
- After you respond "No" to the question "Will the devices be exported from the United States?", you will be automatically directed to the CFG-NE application.
You will need the following information to submit a CFG-NE request:
- The FDA establishment registration number or owner or operator number for the manufacturer
- Product code and marketing status with approval or clearance date for each device.
- Device list.
CFG-NE requestors sign a Shipper's Certification Statement for devices not exported from the United States indicating compliance with applicable requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Detailed instructions are available while in CECATS by clicking on the question mark symbol on the page. Instructions can also be accessed on the CECATS Help Documentation web page.
If you have any questions regarding using CECATS, email cdrhcecats@fda.hhs.gov or call 301-796-7400 and select option 3.
For more information about CECATS, refer to the Exporting Medical Devices Frequently Asked Questions page.
Paper Application or Notification
Upon receipt of a paper application or notification, requestors will be contacted to submit their request using CECATS.
Please contact CDRH Exports Team with questions at cdrhcecats@fda.hhs.gov or call 301-796-7400 and select option 3.
Fees
Section 801(e)(4)(B) of the FD&C Act authorizes the FDA to charge a fee for each certification that is issued within 20 days.
The FDA will provide you an estimate of the fee when you submit your request. The fee for each certificate issued by the FDA is $175.00 for the first certificate and $85.00 for each subsequent certificate from the same request. Each downloadable pdf certificate is limited to 25 pages (including the certificate, the manufacturer's page and the product attachment pages). There is no limit to the number of copies of each certificate that can be requested. However, $175 will be assessed per 25-page increment. When calculating the number of original certificates, fractions are rounded up to the next whole number.
For example: a request for 8 copies of a 10-page certificate will cost $1040 (10 pages x 8 copies = 80 pages); (80 pages / 25 = 3.2 or 4 original certificates); [($175 x 4 originals = $700) + ($85 x 4 additional certificates = $340)] = $1040.
The FDA will invoice quarterly for all certificates issued during that quarter.
FDA FURLS Export Certificate Validator (FECV)
Effective January 2, 2024, the FECV can be used to authenticate electronic export certificates issued by CDRH. Using the web address or Quick Response (QR) code displayed on each certificate, export documents can quickly be authenticated without the need to download any software or even the need for an account. The FECV displays the entire content of export certificates directly from the FDA portal, resulting in a more streamlined, secure, and trustworthy system. This process nearly eliminates the possibility of falsification. The results displayed include the facility establishment name, certificate type, expiration date, certificate number, and the number of pages per certificate as well as an image of the certificate.
CDRH Export Certificate Validation (CECV)
The CECV database, which is updated once a week, can be used to verify the authenticity of paper export certificates issued by CDRH prior to January 2, 2024 and will remain active until January 2, 2026. The results displayed include the facility establishment name, certificate type, expiration date, certificate number, and the number of pages per certificate.
Resources
- Consolidated Appropriations Act, 2023
- Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices - Guidance for Industry and Food and Drug Administration Staff
- Section 801(e)(4)(F)(iv) of the FD&C Act indicates that the “requirements and procedures” related to a denial of certification under section 801(e)(4)(E) of the FD&C Act also applies to denials of certification under section 801(e)(4)(F) of the FD&C Act. For more information about such requirements and processes, stakeholders should consult the above-referenced guidance.