On the US map (Figure 1), there is no mention of FDA's 20^th district office, the Southwest Import District. So how will it fit into the program alignment plan? This is what the agency told Medtech Insight:

"Import Operations will be aligned as a program with its own centralized reporting structure. The new structure for Import Operations establishes five import divisions, with each continuing to oversee all products regulated by the FDA," agency spokeswoman Lyndsay Meyer said.

There will be five imports districts: Southwest Imports; West Coast; Northern Border; Northeast; and Southeast.

"Additionally, four import divisions will be added to the already existing Southwest Imports District," Meyer said. "The import program’s district boundaries are based on workload and other factors, including proximity to Canadian and Mexican borders, as well as the type of operations within the geographic area, and will also provide the opportunity for increased operational coverage across time zones."

'Program Alignment' Falls Into Place: Everything You Need To Know About US FDA's New Inspectional Approach

More from Compliance

More from Policy & Regulation