On March 10, the U.S. Food and Drug Administration (FDA) published a proposed rule to classify posterior cervical screw systems as a Class II device. Since posterior cervical screw systems were in use prior to May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), they are considered unclassified “pre-amendments devices” by the FDA, requiring premarket notification (510(k)). In 2011, the Orthopedic Surgical Manufacturers Association submitted a petition to the FDA to classify posterior cervical screw systems as a Class II device. In September 2012, the Orthopedic and Rehabilitation Devices Advisory Panel to the FDA agreed and recommended that these screw systems be classified as Class II. In the proposed rule issued on March 10, the FDA agreed with the Panel’s recommendation for classification of posterior cervical
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