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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...

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More from Compliance

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• By Brian Bossetta

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FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

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More from Policy & Regulation

‘Dawn Of FDA’s AI Era’ Has Arrived. Makary Announces Early Implentation Of ‘Elsa’ Platform

 
• By Brian Bossetta

US FDA Commissioner Marty Makary says the agency’s generative AI tool ‘Elsa’ will allow employees across the FDA to work more efficiently. The commissioner says Elsa’s launch comes ahead of schedule following a successful pilot program.

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• By Amanda Maxwell

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