Orthopedic/Rehabilitation Devices Panel Meeting 9/8-9

Federal Register notice: FDA is announcing a 9/8-9 virtual meeting of its Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. On 9/8, panel members are scheduled to discuss and make recommendations on the classification of facet screws systems, which are currently unclassified pre-amendment devices, to Class 2 (general and special controls). They will also discuss and make recommendations on the reclassification of non-invasive bone growth stimulators from Class 3 (general controls and premarket approval) to Class 2 (general and special controls). On 9/9, the committee will discuss and make recommendations regarding the classification of three devices, which are currently unclassified pre-amendment devices to Class 2 (general and special controls) —semi-constrained toe (metatarsophalangeal) joint prostheses, intracompartmental pressure monitors, and intra-abdominal pressure monitoring devices. To view the notice, click here.