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  6. Certificate to Foreign Government for Device Not Exported from the United States (CBER)
  1. Exporting CBER-Regulated Products

Certificate to Foreign Government for Device Not Exported from the United States (CBER)

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 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 (i.e., 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, licensed, or are not required to submit a premarket report pursuant to subsection (l) or (m) of section 510 of the FD&C Act, 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 the 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 as required by 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 and Section 510 and 21 CFR Part 607;
  • 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 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 under section 513(f)(2) of the FD&C Act; or
    • was in commercial distribution before May 28, 1976; 
    • is not required to submit a premarket report pursuant to subsection (l) or (m) of section 510 of the FD&C Act; or
    • is the subject of an approved Biologics License Application under section 351 of the Public Health Service Act.
  • Each device is imported or offered for import into the United States;
  • Each device(s) identified is not the subject of an import alert, recall, seizure, injunction, or the subject of any other FDA enforcement action; 
  • 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 Quality System Regulation (21 CFR 820), and the applicable requirements in 21 CFR 600-680 for the identified device(s).

 

How to Request a CFG-NE

To request an CFG-NE from CBER, please send the completed FDA Form 3613g, CERTIFICATE TO FOREIGN GOVERNMENT FOR DEVICE NOT EXPORTED FROM THE UNITED STATES REQUESTS and supporting documents to:

Food and Drug Administration
Center for Biologics Evaluation and Research 
Office of Compliance and Biologics Quality 
Division of Case Management
10903 New Hampshire Ave. 
Building 71, Room G112 
Silver Spring, MD 20993-0002

Or 

By email to CBERBECATS@fda.hhs.gov 

You will need the following information to submit a CFG-NE request.

  • FDA establishment registration number, owner/operator number for the manufacturer, or FDA license number.
  • Product code and marketing status with approval or cleared date for each device.
  • Device list containing the devices to appear on the CFG-NE. The CFG-NE contains spacing to allow for 1-4 columns and 25 – 27 rows. Please note that CBER does not allow attachments to our CFGs or CFG-NEs. 
  • Return shipping label (FedEx Express or UPS, self-addressed). The FDA cannot accept FedEx Home or Ground labels.

CFG-NE requestors must 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). (/regulatory-information/laws-enforced-fda/federal-food- drug-and-cosmetic-act-fdc-act). If you have any questions regarding the CFG-NE or the completion of the FDA Form 3613g, please contact CBERBECATS@fda.hhs.gov.

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. 

 

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.

CBER does not allow attachments to our CFGs or CFG-NEs.

The FDA will invoice quarterly for all certificates issued during that quarter.

 

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