US FDA provided requirement guidelines to allow three categories of medical device into market

Medizinische Geräte Diabetes-Bluttest

US FDA provided requirement guidelines to allow 3 categories of medical device into market that rely on performance criteria to demonstrate safety and effectiveness.

These 3 medical device categories are spinal plating systems, orthopedic non-spinal metallic bone screws and washers, and magnetic resonance receive-only coils.

 

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