Connor Jessica Anne
Biodesign Surgical Innovation Program, Stanford University, Stanford, California 94305, USA.
Semin Pediatr Surg. 2006 Nov;15(4):293-301. doi: 10.1053/j.sempedsurg.2006.07.009.
An examination of and recommendations regarding the approval process for medical devices are presented. The typical pathways and hurdles laid out by the Federal Food and Drug Administration (FDA) are discussed, and options for marketing and use of medical devices are addressed. The first step in the regulatory process is to establish that the new product is, in fact, a medical device. From there, the appropriate classification and the corresponding level of regulatory control that will be required can be identified. The appropriate marketing application will be submitted and is supported by the data necessary to reasonably assure safety and effectiveness. Once the application is submitted, reviewed, and eventually approved, the manufacturer may legally market and sell the medical device. The active involvement of physicians as advisors and innovators in medical device development is imperative to the successful development of safe and effective medical devices. Physicians also fulfill the important obligation of adverse event reporting with all medical devices that they use. The pediatric physician should additionally be aware of the FDA regulations and expectations with respect to devices that will serve pediatric patient populations, of the regulatory options for approval and unapproved use for some devices, and of the special measures taken to protect the rights, safety, and welfare of pediatric patients participating in investigational studies.
本文介绍了对医疗器械审批流程的审查及相关建议。讨论了美国食品药品监督管理局（FDA）制定的典型途径和障碍，并探讨了医疗器械营销和使用的相关选项。监管流程的第一步是确定新产品实际上是一种医疗器械。由此，可以确定适当的分类以及所需的相应监管控制级别。将提交适当的上市申请，并提供合理确保安全和有效性所需的数据支持。一旦申请提交、审查并最终获得批准，制造商就可以合法地营销和销售该医疗器械。医生作为医疗器械开发的顾问和创新者积极参与，对于安全有效的医疗器械的成功开发至关重要。医生还履行对他们使用的所有医疗器械进行不良事件报告的重要义务。儿科医生还应了解FDA关于服务于儿科患者群体的器械的法规和期望、某些器械批准和未经批准使用的监管选项，以及为保护参与研究性研究的儿科患者的权利、安全和福利而采取的特殊措施。
