美國FDA醫(yī)療器械注冊(cè)相關(guān)法規(guī)查詢下載地址

美國FDA https://www.fda.gov/

美國聯(lián)邦法規(guī)https://www.ecfr.gov/cgi-bin/text-idx?SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl

醫(yī)療器械數(shù)據(jù)庫 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

工廠注冊(cè)和器械列名 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

產(chǎn)品分類數(shù)據(jù)庫 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm

FDA認(rèn)可標(biāo)準(zhǔn)數(shù)據(jù)庫 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

審評(píng)指南數(shù)據(jù)庫 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products

FDA賬號(hào)注冊(cè)與登錄 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法規(guī)簡介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上報(bào)https://www.fda.gov/medical-devices/medical-device-safety/reporting-allegations-regulatory-misconduct

召回?cái)?shù)據(jù)庫https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

GUDID數(shù)據(jù)庫 https://accessgudid.nlm.nih.gov/

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