On the eve of US FDA rolling out an historic overhaul of its approach to facility inspections, the agency is finally offering a peek behind the curtain, giving details on how its "program alignment" scheme will operate and be structured.
The upshot: For the medical device industry, FDA's five regional offices – Pacific, Central, Northeast, Southwest, Southeast – will be replaced on May 15 by three distinct divisions across the US encompassing 20 FDA district offices
About 140 investigators, plus management and support staff, will work out of the new device divisions, which will be situated in the northeast, central/southern, and western areas of the country, the agency says