FDA Plans 'Important Changes' to Nationalized Entry Review Program for Imports
The FDA's Office of Import Operations, which is affiliated with the FDA's Office of Inspections and Investigations, is making "important" changes to its Nationalized Entry Review Program on Aug. 4, saying the changes will "revolutionize import operations" by using a technology-driven approach that will streamline operations.
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Specifically, the program will transition from port-by-port reviews to a nationwide system that utilizes staff across multiple time zones to provide for expanded coverage, explores automation opportunities to streamline processes, and optimizes resources to focus on higher-risk products, according to a July 28 emailed alert. The email provided a trade communication guide on the impending change.
E-commerce growth, expanded trade volumes and supply chain complexities are the conditions that have compelled the FDA to move in this direction, according to the emailed alert.
What won't change are review processes and standards, review criteria and risk identification, the alert continued.
"As this is an internal operational enhancement, the NER program modernization requires only one change for industry: Modifying how you contact FDA regarding status of shipments under entry review that have not already gone to the Field for assigned work using the NERInquiry@fda.hhs.gov email address," the FDA said.