The FDA’s Orthopedic & Rehabilitation devices panel detailed its schedule for a 1-day meeting taking place in April of next year, during which the committee will discuss risk classification for shortwave diathermy devices.
The FDA in July initially proposed changing the classification of shortwave diathermy devices to require premarket approval.
The Center for Devices & Radiological Health will hold the panel on April 5, 2013, from 8 a.m. to 6 p.m. at Holiday Inn ballroom, located at 2 Montgomery Village Ave., Gaithersburg, MD 20879, FDA noted.
During the meeting, participants may present data, information or views, orally or in writing, on issues pending before the committee. Written documents must be submitted on or before March 1, 2013.
Oral presentations from the public will be scheduled between 1 p.m. and 2 p.m. on the day of the meeting. Proposed participants who want to present in the meet should send names, addresses and the time requested to make presentations on or before February 21, 2013. The FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session, FDA noted.
The background material will be available prior to the meeting, according to the federal watchdog agency.