医疗器械各类数据库

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases

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

https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/default.htm

Class I / II Exemption （ FDA 豁免的I类和II类设备）

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051549.htm

Medical Device Exemptions （510(k) 豁免目录 ）

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm‍

FDA MDSAP

https://www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap

DMF

https://www.fda.gov/drugs/forms-submission-requirements/drug-master-files-dmfs

eCTD

https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-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