FDA panel favors down-classification of noninvasive bone growth stimulators
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During a meeting of the Orthopaedic and Rehabilitation Devices Panel of the FDA Medical Devices Advisory Committee, panel members found noninvasive bone growth stimulators worthy of down-classification.
Panelists agreed nearly unanimously on the three questions from the FDA on which they deliberated, which led to their conclusions that down-classifying noninvasive bone growth stimulators is a sufficiently safe step for patients and supports manufacturers of the devices. The FDA will consider the panel’s recommendation, as well as comments it receives following an Aug. 17 request for feedback about its proposal to reclassify noninvasive bone growth stimulators.
The products in question are noninvasive bone growth stimulators with product codes LOF and LPQ, which are now post-amendment class 3 devices. FDA proposes they be changed to class 2, subject to premarket notification.
Once the final decision is made, FDA will then issue a proposed rule, proposing how the device will be classified and ask for comments on the proposal.
Comments about the proposed reclassification under docket number FDA-2020-N-1053 are due to FDA on or before Oct. 16.
Class 3 devices typically require premarket approval (PMA) prior to being marketed.
According to the FDA, noninvasive bone growth stimulator devices provide stimulation through electrical and magnetic fields to facilitate the healing of long bone nonunion fractures and spinal fusions.
If finalized, this reclassification will encourage regulation by the FDA that is more efficient because it will allow the companies that manufacturer these devices to submit premarket notification — 510(k) — requirements and general and special controls instead of a PMA, which is what is now required, according to FDA.
During the deliberations, panel members expressed concern about risks of burns, electrical shocks or adverse events with use of the devices that might harm patients, and that the products’ biological aspects or effects were overly vague.
“I don’t see additional harms of the device itself raising enough of a concern to say it needs to stay in class 3,” Jeremy L. Gilbert, PhD, of the department of orthopaedic surgery at Medical University of South Carolina, whose expertise is in biomaterials and materials science, said.
Capt. Raquel Peak, PhD, MPH, USPHS, director, OHT6, FDA Office of Orthopedic Devices, Office of Product Evaluation and Quality, said the FDA is also looking at biocompatibility and other nonclinical studies that can support some of the concerns the panel members raised about these devices.
“We have robust data” for noninvasive bone growth stimulators for established nonunion secondary to trauma or spine fusion or using them as adjunct treatment,” she said. “This product [class] has been in existence for 4 decades,” over which time it has generated only 300 mentions in the medical device reporting (MDR) database.
Peak said about 200 of the MDRs were related to skin irritation and about 60 were related to pain.
“When we looked at the body of literature, there were over 11,000 patients that we have looked to really come up with our analysis as to what the adverse events are. The recalls are very low,” Peak said.
Reference:
Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators – proposed rule
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