Part 2- Changes in the FDA’s Oversight
September 2, 2020
Webinar
Learning Objectives
Upon completion of this webinar recording, participants will better understand:
- Review the definition of Laboratory Developed Tests, LDTs
- Understand CLIA and FDA regulations surrounding LDTs
- Review current Legislative Proposals that could impact the regulations surrounding LDTs: the VITAL Act and the VALID Act
- Discuss the HHS announcement
- Understand staffing and CLIA complexity requirements to perform LDTs
- Review recent COVID lab market updates
Panelists
- Kimberly Zunker, Consulting Manager at Accumen
- Jon Harol, President at Lighthouse Labs