FDA Classifies Medial Knee Implanted Shock Absorber as Class II Device With Special Controls
July 01, 2026
July 01, 2026
WASHINGTON, July 1 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has classified the medial knee implanted shock absorber as a class II medical device with special controls, establishing regulatory requirements intended to ensure safety and effectiveness while easing the pathway for similar devices to reach the U.S. market.
The final rule, effective June 29, codifies the classification of the device under 21 CFR 888.3610 following the agency . . .
The final rule, effective June 29, codifies the classification of the device under 21 CFR 888.3610 following the agency . . .
