Federal Register :: Public Inspection: Physical Medicine Devices: Reclassification of Non-Invasive Bone Growth Stimulators

Federal Register :: Public Inspection: Physical Medicine Devices: Reclassification of Non-Invasive Bone Growth Stimulators

FDA Proposes Reclassification of Non-Invasive Bone Growth Stimulators

Today, the U.S. Food and Drug Administration (FDA) is proposing to reclassify non-invasive bone growth stimulators , postamendments class III devices, into class II, subject to premarket notification.

Read More Non-invasive bone growth stimulator devices provide stimulation through electrical and magnetic fields to facilitate the healing of nonunion fractures and lumbar spinal fusions. If finalized, this reclassification will encourage more efficient regulation by the FDA by allowing manufacturers of these devices to submit premarket notification (510(k)) requirements and general and special controls instead of a premarket approval application (PMA).   Submit comments on this proposal This proposal to reclassify will be open for public comments for 60 days at www.Regulations.gov under docket number FDA-2020-N-1053. Questions? If you have questions about this proposed order, contact the Division of Industry and Consumer Education.