CURRENT AND FUTURE OVERSIGHT AND REGULATION OF LABORATORY DEVELOPED TESTS

About the Product
Includes 1 hour and 15 minute Windows Media Video File and PowerPoint presentations for immediate download.

Laboratory-developed tests (LDTs) continue to thrive and play a significant role in clinical decision making and patient management, particularly in the personalized medicine environment. With laboratories regularly introducing innovative LDTs the trend towards swift expansion and commercialization will likely continue. LDTs are currently regulated under CMS’s Clinical Laboratory Improvements Amendment (CLIA); however, the FDA has expressed interest in regulating tests developed and then offered by labora¬tories. Various stakeholders including industry manufacturers, laboratories and physicians have strong opinions regarding the FDA’s regulation of these new tests as the effects of the potential regulation will mean significant changes for all involved.

• Current LDT regulatory framework
• Analyzing related cases and enforcement actions
• Research Use Only (RUO) final guidance
  • RUO and IVD status determinations
  • Clarity into “intended use”
• Compare/contrast CMS and FDA approaches to regulation

Speakers:
Paul Rudolf, MD, JD
Partner
ARNOLD & PORTER LLP

Abeba Habtemariam
Associate
ARNOLD & PORTER LLP

Participants that will find this webinar most beneficial will be those involved in diagnostic companies. Job titles of attendees that will be most applicable for this session will be:

• Regulatory
• Legal