The USFDA unlocked a new pathway for medical device manufacturers, Effective December 29, 2022, for the CFG-NE (Certificate to Foreign Government – Not Exported). This transformation, driven by Section 3304 of the Consolidated Appropriations Act, 2023, states that the USFDA can now certify certain devices manufactured outside the U.S. that are legally marketed in the U.S., even if they never leave their country of origin before being exported.

Before 2023, the FDA could only issue a CFG for devices exported from U.S. soil.
Now, with CFG-NE, foreign-made devices that have U.S. clearance, approval, or exemption can get official FDA certification for export directly between foreign countries.

Example:
An Indian Class II medical device with FDA 510(k) clearance is sold in the U.S. A German distributor ships it directly to Saudi Arabia.

• No shipment passes through the U.S.
• UAE regulators still want an FDA certificate.
• Solution: The manufacturer applies for a CFG-NE via CECATS.

“Devices Not Exported from the U.S.” means:

These are devices that:

• Manufactured outside the U.S.
• Never shipped from the U.S. in this transaction
• Legally marketed in the U.S. (cleared, approved, or exempt)
• Imported into the U.S. at some stage (even if not for this specific export)

Who Can Apply for a CFG-NE?

Manufacturers meeting the FD&C Act 801(e)(4)(F)(1) criteria:

• Device is legally marketed in the U.S. (510(k), PMA, De Novo, HDE, pre-amendment, or exempt)
• Establishment is FDA-registered and devices are listed (21 CFR Part 807)
• Device complies — no active recalls, import alerts, seizures, or injunctions
• All manufacturers, contract manufacturers, and sterilizers are identified
• Quality systems comply with cGMP requirements

CECATS in 5 Steps

The CDRH Export Certification Application and Tracking System makes it simple:

Fees (FD&C Act 801(e)(4)(B))

• $175 → First certificate
• $85 → Each subsequent certificate from same request
• Limit: 25 pages per certificate PDF (includes attachments)
• Unlimited copies, but fees apply per 25-page increment

Fraud-Proof Certificates

As of January 2, 2024, every digital certificate carries a QR code linking to the FDA FURLS Export Certificate Validator (FECV).
Anyone can instantly confirm:

• Establishment name
• Certificate type & number
• Issue & expiration dates
• Page count
• Preview of the actual certificate

No login needed, validation is public and instant.

The CFG-NE terminates a long-standing gap for foreign-manufactured devices with U.S. market clearance. If the product is made overseas, legally sold in the U.S., and needs USFDA backing for an export without touching the U.S., this is the fast, official route. Apply now in CECATS and keep your global trade moving.