Medical Devices; Orthopedic Devices; Classification of the Resorbable Calcium Salt Bone Vo
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 cl
| Agency | Health and Human Services Department, Food and Drug Administration |
|---|---|
| Document type | Rule |
| Published | 2026-06-05 |
| Summary | 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 p |
| Document number | 2026-11308 |
| Official record | https://www.federalregister.gov/documents/2026/06/05/2026-11308/medical-devices-orthopedic-devices-classification-of-the-resorbable-calcium-salt-bone-void-filler |