The pandemic has focused attention on FDA regulatory policy for more than just vaccines. Diagnostic testing, particularly lab-developed tests (LDT) and in vitro diagnostics (IVD), are also under new scrutiny from policymakers and patient advocacy groups.

In this webinar, you’ll get a refresher of the current regulatory landscape around IVDs and LDTs and how the Verifying Accurate Leading-edge IVCT Development Act (VALID Act) could change it.  

Michael M. Gaba, FDA Practice vice chair, Colleen Faddick, Health Care Operations Practice chair and Christopher C. Rorick, senior policy advisor from the Public Policy Practice Group at Polsinelli, will walk you through why there is significant interest in further regulating these diagnostic mechanisms beyond what the FDA currently has in place via the Clinical Laboratory Improvement Amendments (CLIA) and medical device policy, and the implications for ensuring adequate clinical validation if the VALID Act becomes law.

Webinar Takeaways:

• Understand the current CLIA framework and LDTs
• Comprehend the FDA regulation of IVD tests as medical devices and their regulatory stance towards LDTs
• Understand the history and development of the VALID Act and the framework to define and regulate in vitro clinical tests (IVCT)
• Learn the legislative pathways and prospects for the VALID Act to become law and FDA implementation timelines
• Gain clarity on what it means for a test to have adequate clinical validation
• Recognize the business implications for labs that have historically built their models around the development of LDTs

Ensure your diagnostic development practices are ideally positioned for the future with this webinar. Find peace of mind amidst a changing regulatory landscape.