Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia

项目摘要/摘要 这一行政补充将允许实施数据管理系统，以促进FDA 21 符合CFR第11部分标准的电子系统。这些系统将极大地促进与 美国食品和药物管理局在寻求医疗器械批准时。本行政副刊还要求拨款用于 为Q提交会议和与联邦药品管理局的持续通信提供监管支持。 研究小组得到了密歇根临床与健康研究所的部分内部支持， 但还需要来自第三方监管咨询的进一步专业知识。副刊要求 用于最终确定生物兼容性测试和清洁方案的额外资金。最后，对任务来说很重要 为了公平和包容，需要为翻译文件支持提供资金，以促进非英语 演讲参与者和家庭参与研究。我们的机构临床翻译服务是 能够帮助极低数量的参与者，尽管声明不能支持超过这一点， 推荐第三方援助。 这些补充资金直接符合NIH的数据共享和管理倡议。这个 额外的资金将更有效地允许FDA批准程序的互动和准备， 最终优化研究对患者和家属的价值。此外，增强我们的能力 包括许多非英语背景患者直接解决了一个关键的包括优先事项 多样性、公平性和包容性。

Project Summary/Abstract This administrative supplement will allow implementation of data management systems to facilitate FDA 21 CFR part 11 compliant electronic systems. These systems will greatly facilitate data sharing and transfer with FDA when pursuing medical device approval. This administrative supplement additionally requests funds for regulatory support for Q submission meetings and ongoing correspondence with Federal Drug Administration. The study team is receiving partial internal support from the Michigan Institute for Clinical & Health Research, but additionally requires further expertise from third party regulatory consultation. The supplement requests additional funds for finalizing biocompatibility testing and cleaning protocols. Finally, important to the mission of equity and inclusion, there are requested funds for translational document support to facilitate Non-English speaking participants and families to participate in the study. Our institutions clinical translational services is able to help with extremely low numbers of participants, though stated could not support beyond this, recommending third party assistance. These supplemental funds are directly in accord with NIH data sharing and management initiatives. The additional funds will more effectively allow interaction and preparedness for FDA approval procedures, ultimately optimizing the value of the research to patients and families. Additionally, enhancing our ability to include as many patients from Non-English speaking backgrounds directly addresses a key INCLUDE priority for diversity, equity, and inclusion.