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ORA Device Director: Inspection 'Program Alignment' Scheme Not Ready Anytime Soon; Investigator Training, Retention Pose Challenge For FDA

More details about FDA's new commodity-specific inspectional approach continue to emerge, including news that the Office of Regulatory Affairs is under pressure to train agency investigators while simultaneously dealing with the loss of several highly trained auditors to the agency's device center. All of this comes amid a sign-off process on "program alignment" that will extend all the way to Capitol Hill.

Device manufacturers at risk for an FDA inspection in the coming months shouldn't expect to see any major changes in the agency's audit approach. That's because its new "program alignment" inspectional scheme isn't ready for primetime – mostly because a training program for investigators still needs to be stood up, an FDA official says.

Under program alignment, facility inspections performed by the Office of Regulatory Affairs will be restructured along commodity-specific product lines, including a team focused on device inspections

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