美国FDA 指导原则 参考《联邦食品、药品和化妆品法》中的《工业和食品药品监督管理局工作人员指南》、《管理文件》、《通讯》和其他公共文件中对器械的定义 英文原版.pdfVIP

Contains Nonbinding Recommendations Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents ______________________________________________________________________________ Guidance for Industry and Food and Drug Administration Staff Document issued on November 14, 2022. The draft of this document was issued on December 16, 2021. For questions about this document regarding CDRH-regulat