Manufacturing Method or Process change after PMA approval - MedicalDevice版

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MedicalDevice版 - Manufacturing Method or Process change after PMA approval

相关主题
● Humanitarian Use Devices and Exemption	● the Medical Device Innovation Initiative by FDA
● Humanitarian Use Devices (HUD)	● FDA Regulation of Medical Devices
● FDA Modernization Act of 1997	● How to market a medical device, by FDA
● 什么样的医疗器械是国内没得的	● 美国公司中国分部的研发的 classIII 产品
● 学术第一贴 - 美国器械分类.	● 面试完了，大公司走流程要多久啊
● 学术第二贴 - CDRH	● 医学耗材进出口
● IDE	● regulatory affair certification (RAC) 求助
● PMA	● The Medical Device Industry’s Biggest Challenge: Innovation or Taxes? zz

相关话题的讨论汇总
话题: process话题: pma话题: method话题: day

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发帖数: 25265

Guidance for Industry and FDA Staff - 30-Day Notices, 135-Day Premarket
Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE)
Supplements for Manufacturing Method or Process Changes
http://www.fda.gov/medicaldevices/deviceregulationandguidance/g

(共1页)

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相关主题
● The Medical Device Industry’s Biggest Challenge: Innovation or Taxes? zz	● 学术第一贴 - 美国器械分类.
● chemistry and manufacture control (CMC)	● 学术第二贴 - CDRH
● Design Control Guidance For Medical Device Manufacturers by FDA	● IDE
● 有谁愿意接替版主, 请投条.	● PMA
● Humanitarian Use Devices and Exemption	● the Medical Device Innovation Initiative by FDA
● Humanitarian Use Devices (HUD)	● FDA Regulation of Medical Devices
● FDA Modernization Act of 1997	● How to market a medical device, by FDA
● 什么样的医疗器械是国内没得的	● 美国公司中国分部的研发的 classIII 产品

相关话题的讨论汇总
话题: process话题: pma话题: method话题: day

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