FDA's Total Product Life Cycle Approach to In Vitro Diagnostic Products (IVD's)
🎤 John E. Lincoln | 📅 February 11, 2025 | 🕒 11 AM Eastern Time US
Should your IVD strategy evolve to keep up with the FDA's Total Product Life Cycle approach?
 Why Wait? Secure Your Spot Today. |
This webinar delivers all the answers. This Webinar is for You If you’re part of:
Then this webinar will arm you with the knowledge to navigate the FDA’s evolving landscape with confidence. |
The FDA’s Total Product Life Cycle (TPLC) approach to In Vitro Diagnostic Devices (IVDs) is reshaping regulatory oversight by seamlessly integrating premarket reviews, compliance, and post-market monitoring. In this must-attend webinar, John E. Lincoln—a veteran with 36+ years of expertise in FDA-regulated industries—will demystify the FDA's TPLC strategy and its impact on your IVD processes.
Learn how the FDA is phasing out the Lab Developed Test (LDT) loophole and why their new rule emphasizes greater oversight of IVDs manufactured by laboratories. Equip yourself with actionable insights on the FDA’s evolving regulatory landscape and ensure your IVDs remain compliant, safe, and innovative.
What You'll Gain From This Webinar:
- Clarity on TPLC: Understand the FDA’s comprehensive lifecycle approach to IVD regulation.
- Latest FDA Insights: Key updates from the FDA’s October 2024 IVD presentation.
- Navigate the LDT Rule: Learn how the FDA’s phaseout policy impacts LDT compliance and oversight.
- Agile Innovation: Discover how TPLC oversight supports the development of novel IVDs.
- Expert Guidance: Leverage John E. Lincoln’s 36 years of experience in FDA-regulated industries.
Key Areas Covered:
- IVD Definitions and the TPLC Framework
- Lab Developed Tests (LDTs) and the Final Rule: What You Must Know
- FDA Enforcement Options and Compliance Strategies
- Organizational Units Driving IVD Oversight
- Combining Premarket and Post-Market Oversight for Safer, Smarter Decisions
