美国FDA 指导原则 常规Foley导管.基于安全和性能的路径的性能标准 英文原版.pdfVIP

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美国FDA 指导原则 常规Foley导管.基于安全和性能的路径的性能标准 英文原版.pdf

Contains Nonbinding Recommendations Conventional Foley Catheters – Performance Criteria for Safety and Performance Based Pathway ______________________________________________________________________________ Guidance for Industry and Food and Drug Administration Staff Document issued on August 14, 2020. The draft of this document was issued on September 19, 2019 For questions about this document, contact the DHT3B: Division of Reproductive, Gynecology and Urology Devices at 301-796-7030.

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