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

项目总结/摘要 本行政补充文件将允许实施数据管理系统，以促进FDA 21 符合CFR第11部分的电子系统。这些系统将极大地促进数据共享和传输， FDA在寻求医疗器械批准时。本行政补充文件还要求提供资金， 为Q提交会议和与联邦药品监督管理局的持续通信提供监管支持。 该研究小组正在接受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。补充要求 用于最终确定生物相容性测试和清洁方案的额外资金。最后，对使命很重要的是 为了公平和包容，要求提供翻译文件支助资金，以促进非英语国家的 发言的参与者和家庭参与研究。我们的机构临床翻译服务是 能够帮助极少数的参与者，虽然说不能支持超过这一点， 建议第三方协助。 这些补充资金直接与NIH数据共享和管理计划雅阁。的 额外的资金将更有效地允许互动和准备FDA的批准程序， 最终优化研究对患者和家庭的价值。此外，提高我们的能力， 包括尽可能多的非英语背景的患者直接解决了关键的INCLUDE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.