Post-Conference Master Class: Deep Dive into the Unique Regulatory Schemes for Specialized Devices: IVDs, LDTs, Companion Diagnostics, and Combination Products

July 22, 2016 2:00pm

This master class builds on content covered during the main conference, and delves deeper into specific issues that face practitioners dealing with unique regulation of special devices. Your leaders will provide you with enhanced information specific to in vitro diagnostics, laboratory developed tests, companion diagnostics, and combination productsproducts that are classified as medical devices and will help you thoroughly comprehend the complexities and nuances of these areas of regulatory law

In Vitro Diagnostics, Laboratory Developed Tests, and Companion Diagnostics, Oh My!

  • Understanding FDA’s regulation of in vitro diagnostics (IVDs), including:
    • premarket pathways, including premarket notifications and premarket applications
    • data requirements
    • labeling and promotion
    • research use only (RUO) and investigational use only (IUO) products
    • postmarket requirements
  • Understanding the evolving regulatory landscape for laboratory developed tests:
    • What is a laboratory-developed test (LDT)?
    • Determining whether FDA will regulate an LDT as a medical device or continue to exercise enforcement discretion
    • Challenges for clinical laboratories subject to FDA regulation for the first time
  • Personalized medicineand companion diagnostics
    • What are companion diagnostics?
    • FDA’s regulatory paradigm for companion diagnostics
    • Agency recommendations for developers of companion diagnostics

Unlocking the Combination: Decoding the Unique Challenges of Combination Products

  • Choosing the best submission approach for your product
    • Determining which center has priority
    • Application approaches – single or separate submissions?
  • Developing a robust submission strategy
    • Navigating the regulatory landscape and expectations
    • Design Control considerations
    • Obtaining and managing feedback from regulators
    • Submission content considerations
  • Managing change management
    • Correlating submission content and change management obligations
    • Understanding and evaluating changes
    • Practical approaches to regulatory assessment
  • Overcoming the regulatory and compliance challenges that arise with combination products
    • Recommendations for avoiding some common pitfalls
    • Staying current in the evolving combination product space
    • Case studies – exploring scenarios and solutions