The FDA rescheduled a meeting of its Orthopedic & Rehabilitation Devices Panel, originally slated for April 5, to discuss reclassifying shortwave diathermy devices and pedicle screws.
The shortwave diathermy meeting is now scheduled for May 21 in Gaithersburg, Md., the agency said.
The panel is slated to deliberate over whether to maintain the requirement that shortwave diathermy devices, which use electricity to heat tissue for joint and physiotherapy treatments, be subject to the more-stringent clinical trial requirements of the watchdog agency’s pre-market approval program. The FDA’s orthopedic committee will recommend whether to move the devices to Class II or Class I status, which don’t usually require clinical work.
The original meeting was scrapped due to scheduling conflicts that would have prevented key players from attending.
The FDA also said the panel will discuss the consideration for pedicle screws, similarly to decide whether to recommend maintaining their Class III status or to lower the bar to Class II or Class I for the devices, which are used during some spinal fusion procedures. That meeting is slated for the following day, May 22, also in Gaithersberg.
