HHS FDA Classifies Bone Void Filler With Aminoglycoside Antibacterial as Class II Device
June 06, 2026
June 06, 2026
WASHINGTON, June 6 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a final order classifying a resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial as a Class II medical device with special controls, a step aimed at providing assurance of safety and effectiveness while easing regulatory requirements for future products in the category.
The action, effective June 5, 2026, codifies the cl . . .
The action, effective June 5, 2026, codifies the cl . . .