FDA panel recommends facet screws become class 2 devices
Panel members unanimously recommended that facet screws, which are now pre-amendment devices, be changed to class 2 devices, during the Orthopaedic and Rehabilitation Devices Panel of the FDA Medical Devices Advisory Committee.
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 office because it was the first virtual FDA advisory panel meeting.
Among the 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, some of whose practices are focused on spine surgery performed in patients who may require facet screws to stabilized the spine and promote fusion in the cervical, thoracic or lumbosacral spine.
The panel was instructed that class 2 devices may be medical devices that cannot be ranked as class 1 or may require special controls that help provide reasonable assurance of the device’s safety and effectiveness. Much of the discussion centered on the special controls needed with these devices.
During the open public hearing portion of the meeting, William C. Welch, MD, FAANS, FACS, FICS, of University of Pennsylvania, spoke on behalf of the American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons about facet screws, and in support of the class 2 classification of the devices.
“We have information starting in 1944 on the clinical use of these type devices. This has been well recorded in the literature. There has been a tremendous amount of information brought forward about these products; perhaps not in the most scientific method, but certainly in a practice-type method over the years. The clinical results have shown safety and efficacy, cost-efficiency. In these difficult times, I think this is very 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,” Welch said.
The panel was chaired by Harvey Smith, MD, assistant professor of orthopaedic surgery at Perelman School of Medicine at University of Pennsylvania.
After each panelist stated they agreed with classification of facets screws to class 2, and some briefly stated why, Smith said, “[With] regard to question 3, the panel unanimously agreed with classification as class 2.”
Panelists discussed special controls for facets screws that the FDA proposed for their classification as class 2 devices, which included the following:
- Design characteristic that ensure the geometry and materials are consistent with the intended use;
- Nonclinical performance testing that demonstrates the implant’s function and durability;
- Demonstrated biocompatibility;
- Validation testing that demonstrates cleanliness/sterility of device components and device-specific instruments or the ability to clean and sterilize them; and
- Labeling that adequately conveys device features, its safe and effective use, indications and intended use, and other key information.