On May 15, 2017 the U.S. Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA) announced a reorganization of the FDA Import Offices and Ports of Entry. This reorganization is part of the FDA’s Program Alignment, which was announced in September 2013.
The FDA regions will now be divided into five districts each with a lead office for field activities as well as providing guidance on imports, inspections, and enforcement policy. According to the notice district will be organized by FDA-regulated product, which will, “enhance the effectiveness of our communications, our processes, and our ability to keep pace with scientific innovation and protect public health.”
The ORA Program Alignment will go into effect on May 15, 2017.
The notice can be accessed at:https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ucm549087.htm