US FDA's 'Program Alignment' Inspection Scheme Coming Mid-May; Details Still Murky

The agency's new inspectional approach – which will be structured along commodity-specific product lines – will be ready for primetime on May 15, the device center's compliance chief says.

Mark your calendar: US FDA investigators will begin inspecting device manufacturing facilities using the agency's brand-new "program alignment" inspectional approach on May 15.

That's according to Robin Newman, director of the Office of Compliance within FDA's Center for Devices and Radiological Health, who...

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