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

 
• By Shawn M. Schmitt

For the medical device industry, FDA's five regional offices – Pacific, Central, Northeast, Southwest, Southeast – will be replaced by three distinct divisions across the US encompassing 20 FDA district offices on May 15. Check out the latest US map from the agency showing where the device divisions will be located, and find out what your firm will be facing at its next facility inspection.

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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...

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