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