Medical Devices; Orthopedic Devices; Classification of the Resorbable Calcium Salt Bone Void Filler Containing a Single Approved Aminoglycoside Antibacterial

Resumo

The Food and Drug Administration (FDA) is classifying the resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial into class II (special controls). The special controls that apply to the product type are identified in this order and will be part of the codified language for classification of the resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial. We are taking this action because we have determined that classifying the product into class II will provide a reasonable assurance of safety and effectiveness of the product. We believe this action will also enhance patients' access to beneficial innovative products, in part by reducing regulatory burdens.