美国FDA 指导原则 供多名患者使用的关节镜泵管件。上市前通知(510(K))提交工业和食品药品监督管理局工作人员指南 英文原版.pdfVIP

Contains Nonbinding Recommendations Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions Guidance for Industry and Food and Drug Administration Staff Document issued on December 23, 2021. The draft of this document was issued on January 28, 2020. For questions about this document, contact OHT6: Office of Orthopedic Devices/DHT6C: Division of Restorative, Repair, and Trauma Devices at (301) 796-5650.