FDA panel recommends facet screws become class 2 devices
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Panel members unanimously recommended facet screws, which are pre-amendment devices, be changed to class 2 devices, during the Orthopaedic and Rehabilitation Devices Panel of the FDA Medical Devices Advisory Committee on Sept. 8.
Capt. Raquel Peat, PhD, MPH, USPHS, Director, OHT6, FDA Administration Office of Orthopedic Devices, Product Evaluation and Quality, said this meeting was historic in the FDA because it was the first virtual advisory panel meeting.
Among panel members who agreed that facet screws (FDA product MRW), which were marketed in the United States prior to 1976, be changed from unclassified devices to class 2 devices were neurosurgeons and orthopedic surgeons, including some whose practices are focused on spine surgery in patients who may require facet screws to stabilize and promote fusion in the cervical, thoracic or lumbosacral spine.
Much discussion centered on special controls needed with class 2 devices, which may be medical devices that cannot be ranked as class 1 or may require special controls that provide reasonable assurance of the device’s safety and effectiveness.
During the open public hearing, William C. Welch, MD, FAANS, FACS, FICS, of University of Pennsylvania, spoke on behalf of the American Association of Neurological Surgeons (AANS) and Congress of Neurological Surgeons in support of the class 2 classification.
“The clinical results have shown safety and efficacy and cost-efficiency. In these difficult times, I think this is important to be able to continue to utilize products that have been proven to be effective and efficient with our patients. In speaking with my colleagues of the AANS and the Congress of Neurological Surgeons, we are in support of reclassification of the facet screws based on [their] initial publication in 1944 and subsequent clinical use over the past decades,” he said.
Harvey Smith, MD, who chaired the panel, said after every panelist stated they agreed with classification of facets screws to class 2, “[With] regard to question 3, the panel unanimously agreed with classification as class 2.”
Panelists discussed, at length, special controls for facets screws that the FDA proposed for their classification as class 2 devices, which included design characteristics, biocompatibility, validation testing and labeling information.
- For more information:
- Orthopaedic and Rehabilitation Devices Panel, Medical Devices Advisory Committee; Sept. 8-9, 2020 (virtual meeting).
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