The FDA has announced a public advisory meeting of its Orthopaedic and Rehabilitation Devices Panel, to be held on June 2, from 8:30 a.m. to 3:30 p.m. The meeting will be held in the Walker/Whetstone Rooms at the Holiday Inn in Gaithersburg, Md. The meeting is open to the public.
The committee will discuss and make a recommendation on the reclassification of the non-invasive bone growth stimulator indicated for the treatment of established nonunion fractures acquired secondary to trauma and as an adjunct to the treatment of lumbar spinal fusion surgery for one or two levels. Background information for the topics, including the agenda and questions for the committee, will be available to the public 1 business day before the meeting at http://www.fda.gov/cdrh/panel (http://www.fda.gov/cdrh/panel) (click on Upcoming CDRH Advisory Panel/Committee Meetings).
The advisory committee meeting notice can be viewed at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=669 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=669)