美国FDA医疗器械注册相关法规查询下载地址

美国FDA https://www.fda.gov/

美国联邦法规https://www.ecfr.gov/cgi-bin/text-idx?SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl

医疗器械数据库 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases

CDRH Learn https://www.fda.gov/training-and-continuing-education/cdrh-learn

510K premarket notification https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

工厂注册和器械列名 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

产品分类数据库 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm

FDA认可标准数据库 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

审评指南数据库 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products

FDA账号注册与登录 https://www.access.fda.gov/oaa/logonFlow.htm?execution=e1s1

FDA自由信息法案https://www.fda.gov/regulatory-information/freedom-information

FDA法规简介https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance

FDA UDI https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system#ruleguidance

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

MDR上报https://www.fda.gov/medical-devices/medical-device-safety/reporting-allegations-regulatory-misconduct

召回数据库https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

GUDID数据库 https://accessgudid.nlm.nih.gov/

OSHA's Nationally Recognized Testing Laboratory (NRTL) https://www.osha.gov/nationally-recognized-testing-laboratory-program