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RA/QA Topics
RA/QA professionals within the IVD industry face unique situations while assuring quality and compliance standards are met. AMDM welcomes your suggestions for information to post on this page. Send suggestions to [email protected]
CDRH Learn
https://www.fda.gov/training-and-continuing-education/cdrh-learn
FDA eSubmitter video tutorial
http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm193862.htm
FDA eSubmitter general info
http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm
FDA eMDR
http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm
CDRH Contact Info
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice
OIVD Guidance Documents
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products
IVD Regulation Overview
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm123682.htm
IVD Product Database
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfivd/index.cfm
CDRH Learn
https://www.fda.gov/training-and-continuing-education/cdrh-learn
FDA eSubmitter video tutorial
http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm193862.htm
FDA eSubmitter general info
http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm
FDA eMDR
http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm
CDRH Contact Info
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice
OIVD Guidance Documents
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products
IVD Regulation Overview
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm123682.htm
IVD Product Database
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfivd/index.cfm