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遨游FDA网站

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发表于 2020-5-7 17:07:01 | 显示全部楼层 |阅读模式

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FDA网站实际上是一个大宝藏,有很多有用的信息可以查询:

510k证书信息查询: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
MAUDE信息查询:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
21CFR法规:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
召回、纠正和移除:https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices
UDI信息:https://accessgudid.nlm.nih.gov/
CDRH Learn:https://www.fda.gov/training-and-continuing-education/cdrh-learn
FDA指南文件:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
产品分类信息查询:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm
工厂注册和产品列名:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
Medsun report:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
Total product life cycle:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
MD User Fee:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
创新申报De Novo:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
临床试验DHE:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
PMA指南:https://www.fda.gov/medical-devices/premarket-submissions/premarket-approval-pma
510k/PMN指南:https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k
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