Abstract：
The mission of Food and Drug Administration (FDA)\'s Center for Devices and Radiological Health is to protect and promote public health. It assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products by providing meaningful and timely information about the products we regulate and the decisions we make. On September 17, 2021, an FDA workshop was held to provide information to stakeholders, including members of the spine community, device manufacturers, regulatory affairs professionals, clinicians, patients, and the general public regarding FDA regulations, guidance and regulatory pathways related to spinal device clinical review. It was not intended to communicate any new policies, processes, or interpretations regarding medical device marketing authorizations. This workshop consisted of individual presentations, group discussions, question and answer sessions, and audience surveys. Information-sharing included discussions related to patient-reported outcomes, clinician-reported outcomes, observer-reported outcomes, and performance outcomes. Discussions involving external subject matter experts covered topics related to spinal device clinical studies including definition of a target population, enrollment criteria, strategies for inclusion of under-represented patient groups, reporting of adverse event and secondary surgical procedures, clinical study endpoints, and clinical outcome assessments. A meeting transcript and webcast workshop link are currently posted on the FDA website. Important related issues and challenges were discussed, and an exciting range of new ideas and concepts were shared which hold promise to advance regulatory science, patient care and future innovation related to spinal devices.
摘要：
食品和药物管理局（FDA）的设备和放射健康中心的使命是保护和促进公众健康。它确保患者和提供者能够及时和持续地获得安全，有效,以及高质量的医疗设备和安全的辐射产品，通过提供有关我们监管的产品和我们做出的决定的有意义和及时的信息。2021年9月17日，举行了FDA研讨会，向利益相关者提供信息，包括脊柱社区的成员，设备制造商，监管事务专业人员，临床医生,病人,和公众对FDA的规定，与脊柱器械临床回顾相关的指导和调节途径。它无意传达任何新政策，进程,或关于医疗器械营销授权的解释。这个研讨会由个人介绍组成，小组讨论,问答环节,和受众调查。信息共享包括与患者报告结果相关的讨论，临床医生报告的结果，观察员报告的结果，和绩效结果。涉及外部主题专家的讨论涵盖了与脊柱器械临床研究相关的主题，包括目标人群的定义，入学标准，纳入代表性不足的患者组的策略，不良事件和二次外科手术的报告，临床研究终点，和临床结果评估。会议记录和网络广播研讨会链接目前已发布在FDA网站上。讨论了重要的相关问题和挑战，并分享了一系列令人兴奋的新想法和概念，这些想法和概念有望推进监管科学，患者护理和与脊柱设备相关的未来创新。
