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Legal, Clinical & Regulatory

FDA Issues Direct Final Rule to Alter Outdated Requirements on Biologics Inspections

The rule amends that inspections will be risk-based, not biennial.

UDI: Is Your System Ready for Scale?

UDI requirements have led to layers of regulatory decoding, data collection and dissemination, additional costs and moments of confusion, annoyance and disapproval.

FDA Issues First De Novo Clearance Under Orthopaedic Panel

IlluminOss Medical recently received FDA de novo clearance for the IlluminOss Bone Stabilization System to treat pathological fractures.