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Food & Drug Administration Prior Notice (FDA PN)

Bring Products to U.S. Faster with Our FDA PN Software

Get your food and beverage products to the U.S. market faster. Our FDA PN software automates and streamlines your prior notice submissions, ensuring compliance and reducing delays.

File Prior Notices
Quickly and easily

We’ve simplified and automated the Food & Drug Administration Prior Notice (FDA PN) submission process with our software solutions, allowing business owners to focus on getting their products to market quickly and efficiently.

1

Reduce filing time by 50%

Our automated platform streamlines product populations by enabling bulk entry and generating multiple FDA PN transactions.

2

Affordable plans with a free 30-day trial and no obligations

Start your complimentary 30-day FDA PN software trial today. No credit card or commitment required.

3

Enhanced filing accuracy

Eliminate duplicate data entries and reduce errors through a comprehensive system validation.

4

Immediate responses

Submit FDA PN any time through our software solution and act on responses immediately upon receiving replies from FDA.

Simplify Filing With Our FDA
Prior Notice Submission Software & Service

Simplify your FDA Prior Notice submissions with our flexible solutions. Choose our intuitive web portal for streamlined filing, seamlessly integrate our software with your existing systems to automate the process, or let our experts handle your submissions with our dedicated filing service.

Web portal (direct filing)

For all users 

  • Easy-to-use platform with automated data entry, real-time tracking and advanced reporting.
  • Electronically transmit your shipment information to the U.S. CBP, optimizing efficiency and accuracy.

Integration with in-house systems

For all users 

  • Seamless integration via APIs for fast data transfer to U.S. CBP.
  • Files undergo validation pre-submission to ensure accuracy and compliance.
  • CBP responses will be re-integrated into your dispatch system, boosting automation and workflow efficiency.

FDA PN software filing service

For all users 

  • 24/7 FDA PN filing service to streamline the customs reporting process.
  • Enjoy peace of mind as our team of trade compliance specialists handles all your filing needs.

FDA PN Software Subscription Plans

Expedite your FDA Prior Notice Submissions with flexible subscription plans for our software solutions. Enjoy a complimentary, no-obligation 30-day trial on our web portal to experience the ease and efficiency of our FDA PN software! For new customers only.

Service Price Transactions
Basic
Web
$39
Monthly
39
$1.00 per additional transaction
Lite
Web
$79
Monthly
92
$0.85 per additional transaction
Plus
Web
$149
Monthly
212
$0.70 per additional transaction
Enterprise
Web
$499
Monthly
907
$0.55 per additional transaction

Filing

$50
Monthly
5
$8.00 per additional transaction
  • Pay-per-use: Filing Service $10 per Shipment.
  • Integration Option: One-time Integration Fee $2000 (Includes mailbox for host-to-host EDI/XML integration option).

What is FDA Prior Notice and
How do you Ensure Compliance?

The U.S. Food and Drug Administration (FDA) requires advance notice of all human and animal food, beverage, and dietary supplement shipments entering the U.S. Upon receipt of Prior Notice (PN), FDA will issue a confirmation number in the form of a barcode that must accompany the shipments. This submission process can be simplified and automated through the use of our various software subscriptions.

The following information must be included on all documentation for food shipments:

  • FDA food facility registration number.
  • Name and address of the manufacturer.
  • Last place the product was stored, packed or processed.


Shipments without Prior Notice will likely be detained at the U.S. port of entry and the food is subject to refusal. These shipments may be returned to the shipper or destroyed. FDA considers not filing Prior Notice a “Prohibited Act,” subject to civil and criminal charges.

Note: Prior Notice is not required for home-made non-commercial food shipments shipped by an individual, to an individual, as gifts for personal use. Furthermore, current FDA policy is not to require Prior Notice when food purchased at a commercial establishment is exported or offered for export by a non-commercial shipper for a non-commercial purpose (i.e., from an individual, to an individual, as a gift or as a household good for personal use). Additional exclusion criteria can be found at the FDA website.

FDA Prior Notice
Submission Timeframes

Air 

  • At least 4 hours prior to arrival in the U.S.

Ocean 

  • At least 8 hours prior to arrival in the U.S.

Highway 

  • At least 2 hours prior to arrival in the U.S.

Rail 

  • At least 4 hours prior to arrival in Canada.

Features

Accurate, Automated Data Entry

Eliminate manual data entry errors and save time with our software’s automatic extraction and population of shipment details. Our direct connection to customs systems guarantees the accuracy of your FDA Prior Notice submissions.

Ensures Compliance

Our software automatically validates your submissions against the latest FDA requirements, proactively identifying and alerting you to potential compliance issues before they cause delays. Gain peace of mind knowing your Prior Notice submissions are accurate and compliant.

Bulk FDA PN Submission

Bypass the FDA’s system limitations of only a few Prior Notice (PN) submissions per hour. Our software’s high-volume processing capabilities and efficient upload function allow you to process multiple prior notices simultaneously, saving you valuable time and reducing manual effort.

Talk to us

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