Opportunities for Regulatory Changes to Promote Pediatric Device Innovation in the United States: Joint Recommendations From Pediatric Innovator Roundtables.
Opportunities for Regulatory Changes to Promote Pediatric Device Innovation in the United States: Joint Recommendations From Pediatric Innovator Roundtables.
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DOI：
10.1109/jtehm.2021.3092559
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发表时间：
2021
影响因子：
3.4
通讯作者：
Wolff D
中科院分区：
文献类型：
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作者：
Sanger T;Chang A;Feaster W;Taraman S;Afari N;Beauregard D;Dethlefs B;Ghere T;Kabeer M;Tolomiczenko G;Billig M;Brophy J;Eskandanian K;Espinoza J;Farrugia S;Harrison M;Horvat C;Hoyen C;Koh C;Komiyama A;Nelson K;Kulkarni O;Levy R;Maher K;O'Donnell M;Ponsky T;Richmond F;Richter J;Roy S;Samir S;Suresh S;Stallworth C;Thekkedath U;Toman K;Wall J;West L;Wolff D
目的：本报告的目的是提供儿科利益相关者的见解，他们共同希望促进修订美国现行儿科医疗器械开发监管途径。方法：2020 年 8 月 5 日，一群创新者、工程师、教授和临床医生齐聚一堂，讨论儿科健康新型医疗器械开发的挑战和机遇，以及创建鼓励和加速此类器械研发的监管环境的重要性。 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向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：讨论了几种拟议的策略，这些策略可分为两大类： 1. 消除儿科器械创新的实际和感知障碍； 2.加大对儿科器械创新的激励力度。
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.