How to get a CLIA Waiver for your Medical Device 2015

Topics

• FDAs 2008 CLIA Waiver Guidance and cope with its shortfalls
• FDAs CLIA categorization scoring criteria
• Flex studies based on risk analysis
• Integrating human factors and usability engineering into CLIA Waived products
• Studies and sample panels to evaluate performance near the cutoff
• CLIA Waiver clinical studies for qualitative and quantitative devices
• CLIA Waiver application
• Compliant labeling for CLIA Waived products
• Statistical analysis of data

Who should Attend

• R&D Personnel
• Executives and Senior Managers
• Regulatory Professionals
• Design Engineers
• Risk Management Professionals
• Project Managers
• Clinical Research Professionals