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

Document 2026-11308 is a Final Rule published by the Department of Health and Human Services in the Federal Register on June 5, 2026, with an effective date of June 5, 2026. 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. View the original at https://www.federalregister.gov/documents/2026/06/05/2026-11308/medical-devices-orthopedic-devices-classification-of-the-resorbable-calcium-salt-bone-void-filler.

No. Document 2026-11308 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.