FDA Launches Nationalized Entry Review Program (NER)

We’re excited to share important updates about the Food and Drug Administration (FDA) launching the Nationalized Entry Review (NER) program on Aug. 4 to streamline and standardize import operations.

The program transitions from port-by-port reviews to a nationwide system utilizing technology and staff across multiple time zones. The FDA said it will revolutionize import operations. NER is based on a successful 2022 pilot program that resulted in 70% faster processing times and identified 36% more high-risk products for further testing.

FDA's NER will heavily utilize technology, including the new System for Entry Review and Import Operations (SERIO+) that aims to optimize resource allocations. SERIO+ will be fully deployed in March 2026. SERIO+ will serve as an additional tool to assist NER reviewers, replacing the FDA's previous import review platform. It will integrate multiple tools and databases into a single platform that preserves seamless integration with CBP's systems.

The agency said the program will prioritize the review of higher-risk products, ensuring quicker clearance for safe, low-risk goods, and features a real-time alert system, notifying all ports immediately when a high-risk product is identified. The program aims to improve process times and identify more high-risk products, the FDA said. We understand these transitions can raise questions and concerns, but these enhancements will ultimately lead to smoother, faster processing for everyone.

To assist with this transition, the FDA emphasizes that ITACS is the preferred method for status inquiries and submitting entry information or documents. ITACS will continue to be an essential tool in this new process. Additionally, the FDA has provided the following insight to Customs brokers who may experience more holds or delays in processing as the national reviews proceed:

• It is more important than ever to ensure your entry data is correct and appropriately transmitted.
• CASAS provides all clients with an “FDA Monthly Device Entry Report” that highlights the discrepancies between what is registered with the FDA and what is being transmitted via entries. Focus on using these reports to start your proactive approach to minimizing delays and reviews of your entries. If you are not receiving this report, please let us know so you can be added to the list of recipients.

We’re here to support you through this transition. If you have any questions or concerns, please reach out to us!