FDA Proposes to Reclassify Bone-Growth Stimulators
The FDA plans to reclassify noninvasive bone-growth stimulators from Class III to Class II, following recommendations from the agency’s orthopaedic devices advisory committee.
The move means that devicemakers would not have to file a premarket approval application (PMA), but would be subject to premarket notification requirements and special controls.
The FDA said that noninvasive bone-growth stimulator devices, which are intended to promote osteogenesis as an adjunct to primary treatments for fracture fixation or spinal fusion, can be reclassified because there is enough information available to establish special controls for the risks identified.
If an order is finalized, manufacturers that intend to market this type of device would need to apply for a 510(k) clearance prior to marketing it.