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  1. Exporting Medical Devices

Devices Not Exported From the United States

Update: March 29, 2023

On December 29, 2022, the Consolidated Appropriations Act, 2023 was signed into law. Section 3304 of this Act amends section 801(e)(4) of the FD&C Act and modifies the Agency’s authority to issue certain certificates.

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Overview

On December 29, 2022, the Consolidated Appropriations Act, 2023 was signed into law. Section 3304 of this Act amends section 801(e)(4) of the FD&C Act and directs the FDA to provide certification for devices that are not exported from the United States if certain conditions are met. Manufacturers of devices not exported from the United States, 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 United States that are cleared, approved, or are not required to submit a premarket report, and are shipped from outside of the United States 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(s) identified herein is authorized to be marketed within the United States 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 United States;
  • Each device(s) 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(s).

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 FDA review, upload additional documents such as mailing labels, and clone (auto populate) previously submitted application information for future requests using the "clone" icon.

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:

  • FDA establishment registration number or owner or operator number for the manufacturer
  • Product code and marketing status with approval or cleared date for each device.
  • Device list.
  • Return shipping label (FedEx Express or UPS, self-addressed). Please note the FDA cannot accept FedEx Home or Ground labels.

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

Effective October 1, 2016, upon receipt of a paper application or notification, requestors will be contacted to submit their request using CECATS.

If you have question, contact CDRH Exports Team at cdrhcecats@fda.hhs.gov or call 301-796-7400 and select option 3.

Shipping Label

You are required to provide a prepaid FedEx Express or UPS, self-addressed label for the FDA to mail your certificates or permit to you once they are printed. FedEx Ground or Fedex Home labels are not accepted. The label should be unique for each application.

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 working days.

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. Certificates are provided on anti-counterfeit paper with an embossed gold seal.

Each 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.

CDRH Export Certificate Validation (CECV)

You can use the CECV database, which is updated once a week, to verify certificates issued by CDRH. The results displayed include the facility establishment name, certificate type, expiration date, certificate number, and the number of pages per certificate.

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