Connect & Solve
Trade Q&A
How to obtain the PN No. that needs to be submitted to the US FDA?
Resolved
SERVICE
TRACKING NO. 20260105 / GLOBAL Zhongshen Trade · 23+ Years of Expert Trade Agency
Trade Challenges?
No import/export license, customs delays,
or complex compliance issues.
or complex compliance issues.
Our Solution
One-stop full-chain agency: ensure efficient
clearance and fund security.
clearance and fund security.
Cost OptimizationUrgent ClearanceGlobal ResourcesCompliant Rebates
We have a batch of food products to export to the United States, and the freight forwarder said we need an FDA PN number. How exactly do we apply for this number, and how long does the process take?
Eric ZhouYears of service：6Customer Rating：5.0
Senior Manager of Foreign Exchange & Tax RebatesStart a Chat
The Prior Notice (PN) number from the U.S. FDA must be submitted through the FDA's Prior Notice System Interface (PNSI). You need to complete the submission at least 4 hours (for air freight) or 8 hours (for sea freight) before the goods arrive at U.S. ports. Key steps。
1. Register an FDA account to obtain a Submitter ID。
2. Prepare complete information: manufacturer，shipper，F(xiàn)DA product code，expected arrival information，etc。
3. Submit through the PNSI system。
Note: Incorrect information may result in the detention of goods. It is recommended to entrust a qualified FDA agent to handle this. The system will immediately generate a PN confirmation number，formatted as PNC-YYYY-XXXXX. Be sure to retain the confirmation letter，as it is an essential document for customs clearance.
Victor SunYears of service：5Customer Rating：5.0
Trade Risk Control ManagerStart a Chat
From a logistics operational perspective, the PN number must be obtained before the ship departs or the flight takes off. We recommend the following arrangement: initiate the PN application immediately after booking the shipping space, and reserve at least 2 working days for this process. The information required for the FDA system includes: the bill of lading number, the ship's name and voyage, the estimated arrival time, and the FDA product code (PC code) corresponding to the specific product name. There's a pitfall here: many customers fill in inaccurate PC codes, resulting in FDA rejecting the declaration. It's best to have your U.S. consignee provide accurate FDA product codes. Additionally, the PN number must be provided to the freight forwarder immediately. We need to note it during the AMS/ISF declaration, otherwise the destination port will not be able to link the data, and customs clearance will still be delayed.
Daniel XuYears of service：10Customer Rating：5.0
Director of Import & Export OperationsStart a Chat
From the perspective of business negotiations, the responsibility for applying for a PN number must be clearly stipulated in the contract. American buyers typically require sellers to handle the PN application, but the fees can be negotiated. It is recommended that you specify in your quotation: "The price includes the service fee for FDA Prior Notice application," which not only demonstrates professionalism but also covers the costs. If the buyer insists on applying for it themselves, you must require them to provide a PN confirmation letter at least 3 working days before the shipping schedule and include the following clause in the contract: "If the PN number is delayed or incorrect and results in failed customs clearance, the responsibility shall be borne by the applicant." Additionally, you can demonstrate professionalism in email communication by stating: "To ensure compliance with FDA FSMA regulations, we will coordinate with a professional team to handle the Prior Notice matter and expect to provide the confirmation letter by XX date." This will reassure the buyer and avoid future disputes.