目的：分析美国食品药品监督管理局（FDA）对植入式闭环神经刺激器在注册递交时临床评价监管情 况，旨在为国内该类产品的上市前临床评价提供思路。方法：检索植入式闭环神经刺激器的临床应用和原 理，梳理植入式闭环神经刺激器在美国FDA的上市情况，汇总分析闭环脊髓神经刺激器（closed-loop spinal cord stimulation，CL-SCS）、闭环脑深部神经刺激器（closed-loop deep brain stimulation，CL-DBS）等医疗器械 的临床评价路径和临床试验设计。结果：美国FDA要求闭环刺激器通过临床试验路径进行临床评价，临床 试验设计应基于临床预期用途、闭环原理、适用人群等，选择合适的临床评价指标、随访时间、样本量等。 结论：通过对植入式闭环神经刺激器在美国FDA上市前临床试验设计思路和方案进行总结，从中获得一定 启示，可为类似产品在我国境内上市监管提供参考。

To analyze the regulatory status of clinical evaluation for implantable closed-loop neurostimulators during registration submissions to the U.S. Food and Drug Administration (FDA), aiming to provide insights for the pre-market clinical evaluation of such products in China. Methods: We retrieved data on the clinical applications and mechanisms of implantable closed-loop neurostimulators, reviewed their market approval status in the U.S., and summarized and analyzed the clinical evaluation pathways and clinical trial designs for medical devices such as closed-loop spinal cord stimulation (CL-SCS) and closed-loop deep brain stimulation (CL-DBS). Results: The U.S. FDA requires closed-loop stimulators to undergo clinical evaluation via the clinical trial pathway. Clinical trial designs should be based on the intended use, closed-loop mechanism, and target population, while appropriately selecting clinical evaluation endpoints, follow-up durations, and sample sizes. Conclusion: By summarizing the design rationales and protocols for pre-market clinical trials of implantable closed-loop neurostimulators under FDA regulation, this study offers valuable insights that can serve as a reference for the regulatory approval of similar products in China.