FDA has published dates for the next meeting of the Orthopaedic and Rehabilitation Devices Panel. The Panel will convene via an online platform on Tuesday, September 8th and Wednesday, September 9th. Per the announcement, “during session 1, the committee will discuss and make recommendations regarding the classification of facet screws systems which are currently unclassified pre-amendment devices to Class II (general and special controls). During session II, the committee will discuss and make recommendations regarding the reclassification of non-invasive bone growth stimulators which are currently post-amendment devices from Class III (general controls and premarket approval) to Class II (general and special controls).”
Webcast link for Day 1: https://fda.yorkcast.com/webcast/Play/8ef8ac6b36f244beaced2a3031eebc621d.
Webcast link for Day 2: https://fda.yorkcast.com/webcast/Play/0e1b175674de4b1e8a4675cf5096aa601d.
Background material (posted at least two business days before the meeting): https://www.fda.gov/advisory-committees/medical-devices-advisory-committee/orthopaedic-and-rehabilitation-devices-panel.