CFG-NE Certificate for Medical Devices | Liberty Management Group

A Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE) is an official document issued by the FDA for legally marketed devices in the U.S. that are manufactured outside of the United States but not exported from the US and comply with the FD&C Act.

CFG-NE is a self-certification process. By completing the application, a firm confirms:

The facility is registered and the device is listed with the FDA.
The product is legally marketed in the U.S. and is not under recall.
All manufacturing facilities comply with FDA regulations.
The product is not currently being exported from the U.S.

Requirements to Obtain a CFG-NE

Valid medical device establishment registration for facilities located outside the U.S.
Devices must be properly listed with the FDA.
510(k) clearance or Premarket Approval (PMA) must be active, unless exempt.
Compliance with 21 CFR 801/809 (Labeling) and 21 CFR 820 (Good Manufacturing Practice).
No subject of import alerts, recalls, seizures, or injunctions.

Application Process & Fees

Requests are submitted via the CECATS (CDRH Export Certification Application and Tracking System) through the FDA FURLS account.

Description	FDA Fee (CDRH)
First Certificate	$175
Additional Certificates (same request)	$85 each

Need Assistance with CFG-NE?

Liberty Management Group assists with FDA registration, device listing, and certificate applications.

Email: info@fdahelp.us | Phone: +1 (630) 270-2921

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