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By: Douglas Stearn The data is in. A new automated system for determining whether FDA-regulated products can enter the United States is allowing us to make decisions faster and more efficiently. Quick admissibility decisions are critical to commerce, especially when perishable products are involved. The new system brings better response times while still protecting consumers. FDA has used an automated system to assist in making decisions about the admissibility of FDA-regulated products since the early 1990s. In 2015, FDA began piloting a new system, the Automated Commercial Environment (ACE). It features modernized infrastructure that can more quickly process larger amounts of data. Part of the pilot involved the collection of additional shipment information, such as intended use codes, that could assist in automatically making informed admissibility decisions. Results were promising. So in July 2016, the use of ACE and the provision of additional data were required for everyone seeking to import FDA-regulated goods into the U.S. Products offered for import into the U.S. must comply with the same standards as domestic products. ACE is one of many tools FDA uses to determine the admissibility of imports – tools that also include inspections of manufacturing plants abroad, physical inspection of goods arriving at our ports, and import alerts which flag manufacturers or products which have had previous violations. By better automating the admissibility process with respect to lower-risk products, FDA can focus more resources on higher-risk products. Continue reading |
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