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

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. This means a majority...