Episode description
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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