FDA Propose Non-Invasive Bone Grown Stimulators Reclassifying from Class III to Class II

The US Food and Drug Administration (FDA) proposed reclassifying non-invasive bone grown stimulators from Class III to Class II, reducing the regulatory burdens and allowing the devices to be marketed with 501(k) clearance rather than requiring premarket approval. The original amendment for non-invasive bone grown stimulators was in 1979, and the post amendment changes comes part of the FDA’s approach to review PMA approval prior to 2010. The proposed reclassification, however, would only apply to non-invasive bone growth stimulators under product codes LOF and LPQ, and does not apply to invasive bone growth stimulators under product code LOE. 

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