Artif Organs. 1982 Feb;6(1):91-118.
This is a revision of the IDE Application Form, "How to Comply with the Food and Drug Administration's New 'Investigational Device Exemption (IDE)' Regulations, Including an Application Form" originally published in Artificial Organs, Volume 4, Number 4, November 1980. This publication updates the IDE application form to facilitate compliance with the amended investigational device exemption regulations now in effect.
这是对《IDE申请表》的修订,该表最初发表于1980年11月《人工器官》第4卷第4期,标题为《如何遵守美国食品药品监督管理局新的“研究性器械豁免(IDE)”法规,包括申请表》。本出版物更新了IDE申请表,以促进符合现行修订后的研究性器械豁免法规。