医疗器械各类数据库
510K K号查询(含代理公司批准数量查询)
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
PMA 查询
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm
FDA产品分类查询
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm
FDA官方指南
https://www.fda.gov/regulatory-information/search-fda-guidance-documents
FDA企业注册和产品列名
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
UDI公众查询数据库
https://accessgudid.nlm.nih.gov/
MAUDE database(制造商数据库)
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM
Import Alerts (进口警报)
https://www.fda.gov/industry/actions-enforcement/import-alerts
FDA's Recalls (FDA的召回)
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm
483和警告信
Class I / II Exemption ( FDA 豁免的I类和II类设备)
Medical Device Exemptions (510(k) 豁免目录 )
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm
FDA MDSAP
DMF
https://www.fda.gov/drugs/forms-submission-requirements/drug-master-files-dmfs
eCTD
OTC -Over The Counter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfIVD/Search.cfm
FDA IVD法规
https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation
FDA 药物滥用检测
https://www.fda.gov/medical-devices/in-vitro-diagnostics/drugs-abuse-tests
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