FDA regulators plan to meet next month to review a handful of medical devices and possibly recommend reclassification for spinal fusion ‘spheres’ and both stair-climbing and mechanical wheelchairs.
The agency noted in the Federal Register that its Orthopaedic & Rehabilitation Devices Panel will meet December 12 to review the technologies based on new reviews of their safety and effectiveness.
The agency plans to take another look at spinal sphere devices, which are inserted in the spine "to help provide stabilization and to help promote inter-vertebral body fusion" during fusion procedures. The technology is considered a "pre-amendment" device because they’ve been on the market since 1976, and are treated as unclassified devices reviewed under the less-stringent 510(k) program, according to the notice.
The advisory panel also plans to review stair-climbing wheelchairs, as requested last year by DEKA Research & Development Corp. DEKA was founded by New England tech celebrity Dean Kamen, who perhaps most commonly known for having invented the Segway but has also invented revolutionary products in robotic prosthetics and water purification systems.
DEKA developed the iBOT system, an FDA-approved high-tech wheelchair that can navigate difficult terrain, climb up or down stairs and rise to "stand" at eye level. DEKA requested in November 2012 that the FDA reconsider classifying the devices from the highest-risk Class III category to a Class II, where they will fall under the 510(k) review pathway. Earlier this year the FDA issued a proposed order to do just that, and the order is now awaiting finalization.
The panel will also discuss possible reclassification of less advanced mechanical wheelchairs to a higher-risk category, from Class I to Class II, the FDA said.
"The committee will discuss whether general and/or special controls are appropriate to demonstrate a reasonable assurance of safety and effectiveness of mechanical wheelchairs and whether, if reclassified to Class II, these devices should be exempt from premarket notification (510(k)) requirements," according to the FDA notice.
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