Laboratory-Developed Tests - Medical devices 2017

This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests.

Why should you Attend:

This 1 hour session will explore the reasons FDA has for claiming such jurisdiction, and the objections to FDAs' position articulated by the clinical laboratory community, and others.

Areas Covered in the Session:

• "Enforcement Discretion" and how it has been applied to LDT regulation
• Extent of CLIA '88 authority over LDT performance
• Role of US Congress in answering the question of FDA authority
• International (EU) approach to LDTs

Who Will Benefit:

• QA Specialist
• Complaint Coordinator
• Regulatory Specialist
• QA Manager
• QA Trainer
• All above in Medical Device companies