FDA Committee Calls for Class 3 Device Designation on Spinal Sphere Devices

After meeting recently, a U.S. Food and Drug Administration committee agreed spinal sphere devices should be classified as Class 3 devices, which require premarket approval, according to a Medscape report. The Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee met recently and made the recommendation. John Kelly, MD, chaired the panel and agreed that spinal devices should be Class 3-designated.

A medical device with a Class 3 designation is the FDA's highest risk category.

Spinal sphere devices include those manufactured from metallic or polymeric materials which are intended to be permanently implanted.

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