The Return of VALID: What the Future Holds for IVDs and LDTs – Webinar Recording/Transcript
Product Details
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 presentation, 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.
Presentation 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.
Meet Your Presenters
Michael M. Gaba is the current FDA Practice vice chair for Polsinelli. He provides strategic FDA regulatory, Medicare policy and federal relations counsel to an array of companies developing a variety of products in the life sciences space, whether traditional medical devices, digital health-based products, biotechnologies, biologic-device combinations or pharmaceuticals.
Colleen Faddick serves as chair of Polsinelli’s Health Care Operations practice, focusing on Medicare, Medicaid and other payer reimbursement and regulatory issues. She works with hospitals, large physician groups, dialysis suppliers, medical device companies, pharmacies, clinical laboratories, durable medical equipment companies and other healthcare entities.
Christopher C. Rorick, senior policy advisor of the Public Policy Practice Group at Polsinelli, brings 25 years of experience in both state and federal government service and government relations. His focus is on healthcare and health science policy representing numerous physicians, nursing and medical research associations.
Who Will Benefit
- Quality assurance leaders and staff
- Regulatory affairs leaders and staff
- Quality system regulators
- R&D leaders and staff
- IVD in-house counsel