Medical Devices; Orthopedic Devices; Classification of the Resorbable Calcium Salt Bone Void Filler Containing a Single Approved Aminoglycoside Antibacterial
Key claim: The FDA is classifying the resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial as a Class II medical device subject to special controls to provide reasonable assurance of safety and effectiveness.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) 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.
Why this matters
Class II classification with special controls establishes a defined regulatory pathway for this combination orthopedic device, letting future manufacturers pursue 510(k) clearance rather than premarket approval. For patients and surgeons, this can broaden availability of bone void fillers that deliver local antibiotic release while codifying the safety and effectiveness controls FDA expects.