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 amdm_secretary@att.net
CDRH Learn
http://www.fda.gov/Training/CDRHLearn/default.htm
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
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm154052.htm
OIVD Guidance Documents
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070274.htm
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
http://www.fda.gov/Training/CDRHLearn/default.htm
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
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm154052.htm
OIVD Guidance Documents
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070274.htm
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