遨游FDA网站

RA小编辑

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