Health Law Daily Wrap Up, MEDICAL DEVICES—FINAL RULES: Classification of the resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial, (Jun 9, 2026)

By WK Editorial Staff

The classification will also enhance patients’ access to beneficial innovative products, in part by reducing regulatory burdens.

The FDA classified 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. The FDA is taking the action because it determined that classifying the product into class II will provide a reasonable assurance of safety and effectiveness of the product (Final Rule, 91 Fed. Reg. 34148 (June 5, 2026)).

Dates. This order is effective June 5, 2026. The classification was applicable on May 17, 2022.

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