PDF(Pubmed)
Abstract：
The classification of medical devices by the Food and Drug Administration (FDA) involves rigorous scrutiny from specialized panels that designate devices as Class I, II, or III depending on their levels of relative risk to patient health. Posterior rigid pedicle screw systems were first classified by the FDA in 1984 and have since revolutionized the treatment of many spine pathologies. Despite this early classification by the FDA, posterior cervical pedicle and lateral mass screws were not reclassified from unclassified to Class III and then to Class II until 2019, nearly 35 years after their initial classification. This reclassification process involved a decades-long interplay between the FDA, formal panels, manufacturers, academic leaders, practicing physicians, and patients. It was delayed by lawsuits and a paucity of data demonstrating the ability to improve outcomes for cervical spinal pathologies. The off-label use of thoracolumbar pedicle screw rigid fixation systems by early adopters assisted manufacturers and professional organizations in providing the necessary data for the reclassification process. This case study highlights the collaboration between physicians and professional organizations in facilitating FDA reclassification and underscores changes to the current classification process that could avoid the prolonged dichotomy between common medical practice and FDA guidelines.
摘要：
美国食品和药物管理局（FDA）对医疗器械的分类涉及专门小组的严格审查，这些小组将器械指定为I类，II,或III，取决于他们对患者健康的相对风险水平。后路刚性椎弓根螺钉系统于1984年首次由FDA分类，此后彻底改变了许多脊柱病变的治疗方法。尽管FDA进行了早期分类，颈椎后路椎弓根和侧块螺钉直到2019年才从未分类重新分类为III类，然后重新分类为II类，距离其初始分类已近35年。这种重新分类过程涉及FDA之间长达数十年的相互作用，正式小组,制造商,学术领袖,执业医师,和病人。由于诉讼和缺乏数据证明有能力改善颈椎病变的结果而被推迟。早期采用者在标签外使用胸腰椎椎弓根螺钉刚性固定系统，有助于制造商和专业组织为重新分类过程提供必要的数据。本案例研究强调了医生和专业组织在促进FDA重新分类方面的合作，并强调了当前分类过程的变化，可以避免常见医疗实践和FDA指南之间的长期二分法。
