Laboratory Developed Tests under FDA`s Thumb 2015

Topics

• Applicable regulations
• Reasons for FDA regulation
• Identify logistical risks
• Use and availability of LDTs
• Steps for implementation

Who should Attend

• Pathology practice groups
• Clinical laboratories
• Practitioners
• Medical institutions (hospitals) using Laboratory Developed Tests
• Medical device and diagnostic manufactures
• Healthcare maintenance organizations
• Regulatory affairs managers for IVD manufacturers
• Risk managers for healthcare practices
• Cost control consultants for healthcare practices