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FDA Guidances On Orthopedic, Imaging Devices Demonstrate Safety And Performance Pathway Use

 
• By Sue Darcey

The US agency released three new guidance documents on 10 December detailing how certain devices can be cleared through a safety and performance pathway.

spinal plating system

The US Food and Drug Administration shows how certain orthopedic and advanced imaging medtech products can be 510(k)-cleared through use of a safety and performance pathway spelled out in three final guidance documents issued on 10 December.

The guidances cover safety testing and performance steps for spinal plating systems, non-spinal metal bone screws and washers, and magnetic resonance (MR) receive-only coils

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