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图12、美国III类器械PMA审查流程及要求

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所属报告：

医药生物行业中国医疗器械“智造”出海之路：因地制宜创新启航-240417（39页）.pdf

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FDA鼓励申请人通过预提交会议（Pre-submission meetings）与 FDA 积极沟通，以促进 PMA 流程的顺利进行，申请人可借此与 FDA商讨 IDE申请和后续的临床试验设计，加快监管流程，这一过程通常需要 75-90天（紧急公共卫生需求可缩短至 21天）。随后申请人需要递交完整的 IDE申请，涵盖所有的早期临床、动物试验、实验室测试信息以及后续的研究计划等，FDA会在确认收到申请后的 30 天内进行回复。在等待 FDA 答复的同时，申请人还需要向所有计划开展临床试验的医疗机构申请 IRB许可，这一流程也需要花费大约 3-6个月的时间。整体而言，完整的 IDE申请流程可能需要花费 6-12个月的时间。2）临床试验：通常由可行性研究和关键性临床两部分组成。可行性研究样本数量通常较少，患者人数一般不超过 100人，主要是为了确定关键性临床的试验设计。此外，部分创新医疗器械还可以通过早期可行性研究（EFS，EarlyFeasibility Study）来验证器械的早期安全性和有效性，并在此过程中探索最优的器械设计和手术流程。EFS 所需的患者人数更少，通常在 10-15人，在积累了足够的安全性和有效性数据的前提下，EFS 结束后也可以直接推向关键性临床，这为创新医疗器械提供了一条更简便、成本更低的临床路径。关键性临床一般是多中心的大规模随机对照临床试验，试验器械需要与现有的最佳治疗手段进行随机对照以证明其非劣，入组患者人数可能多达 1000人，部分植入式的器械还需要进行为期 1年及以上的随访（如心脏瓣膜、药物洗脱支架等），整体临床试验要求较高。

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