Live! #74 – A New Era of LDT Oversight: Adapting to FDA Regulations

Device Advice by RQM+

This show was recorded 30 November 2023 and can be viewed on our website ⁠⁠⁠⁠here⁠⁠⁠⁠. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠. We have a ton of on-demand content there, too. Thank you for tuning in! 🙏

Takeaways

• LDTs have historically been subject to enforcement discretion by the FDA, but as they have become more complex and used in higher-risk settings, the FDA is proposing regulations to ensure their safety and effectiveness.
• Examples of issues with LDTs include false positive or false negative results, misdiagnosis, and fraudulent practices.
• IVDR regulations in the EU are influencing the FDA's approach to LDT oversight, and manufacturers may need to comply with both sets of regulations.
• Preparing for LDT regulations involves understanding the current LDT portfolio, identifying gaps in data and validation, and considering the impact on resources and timelines.
• Potential pitfalls include challenges in determining the classification of LDTs, ensuring compliance with validation requirements, and managing resource constraints.
• The proposed rule has received significant feedback and comments, with some expressing concerns about the need for regulation and the potential impact on innovation and patient access to tests.
• Implementing LDT regulations may require significant financial resources, including costs for testing, clinical trials, and quality management systems.
• The chances of the proposed rule going into effect are uncertain, but the FDA is committed to addressing the concerns and evidence of issues with LDTs.

Chapters

00:00 Introduction

03:25 History and Background of Laboratory Developed Tests (LDTs)

05:46 Impact of FDA Regulations on LDTs

08:41 Examples of Issues with LDTs

14:00 Speculation on the Regulatory Process

18:38 Influence of IVDR Regulations on FDA

20:38 Opportunities for IVD Manufacturers

25:51 Preparing for LDT Regulations

28:06 Potential Pitfalls and Challenges

35:15 Comparison of LDT Regulations with IVDR

41:41 Comments and Feedback on the Proposed Rule

44:35 Scenario: Using FDA-Cleared Test with Different Specimen Types

46:21 Supporting Team Members in Implementing Changes

51:49 Realistic Cost of Implementing LDT Regulations

52:14 Chances of Proposed Rule Going into Effect

52:18F DA's Mission and Authority to Regulate

53:17 Closing Remarks and Call to Action

Panelists

• Nancy Morrison, RAC – Vice President, Intelligence & Innovation
• Margot Borgel, Ph.D. – Director, IVD Intelligence & Innovation
• Eila Pattee, Principal Consultant
• Andrew Lakey, Ph.D. – Senior Consultant
• Theresa Miles – VP, Client Portfolio Management (moderator)

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