Objective: The purpose of this report is to provide insight from pediatric stakeholders with a shared desire to facilitate a revision of the current United States regulatory pathways for the development of pediatric healthcare devices. Methods: On August 5, 2020, a group of innovators, engineers, professors and clinicians met to discuss challenges and opportunities for the development of new medical devices for pediatric health and the importance of creating a regulatory environment that encourages and accelerates the research and development of such devices. On January 6, 2021, this group joined regulatory experts at a follow-up meeting. Results: One of the primary issues identified was the need to present decision-makers with opportunities that change the return-on-investment balance between adult and pediatric devices to promote investment in pediatric devices. Discussion/Conclusion: Several proposed strategies were discussed, and these strategies can be divided into two broad categories: 1. Removal of real and perceived barriers to pediatric device innovation; 2. Increasing incentives for pediatric device innovation.

中文翻译：

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监管变革以促进美国儿科器械创新的机会：儿科创新者圆桌会议的联合建议

目的：本报告的目的是提供儿科利益相关者的见解，共同希望促进修订当前美国儿科医疗保健设备开发的监管途径。方法：2020 年 8 月 5 日，一群创新者、工程师、教授和临床医生会面，讨论开发用于儿科健康的新医疗器械的挑战和机遇，以及创造鼓励和加速研发的监管环境的重要性的此类设备。2021 年 1 月 6 日，该小组与监管专家一起参加了后续会议。结果：确定的主要问题之一是需要为决策者提供改变成人和儿科设备之间投资回报平衡的机会，以促进对儿科设备的投资。讨论/结论：讨论了几个建议的策略，这些策略可分为两大类： 1. 消除儿科器械创新的实际障碍和感知障碍；2. 加大对儿科器械创新的激励力度。