In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols engages with Carmen Brown, the regulatory and quality affairs manager at Proxima Clinical Research. They delve into the specifics of In Vitro Diagnostics (IVDs) and explore the challenges and considerations faced by medical device manufacturers in the IVD pathway. Whether you're an industry veteran or new to the field of medical diagnostics, this conversation will enlighten you about the nuances of IVD regulatory compliance, risk assessment, and FDA interactions.

Episode Highlights:

1. IVDs are a Specialized Medical Device: Learn how IVDs, which include reagents, instruments, or systems for diagnosis, differ from other medical devices and what specific regulatory pathways they follow.
2. Risk Levels in IVDs: Understand the significance of classifying IVDs into class one, two, or three based on the risk of false or inaccurate results, and how this impacts regulatory strategy.
3. Pitfalls in Performance Characteristic Evaluation: Discover the complexities involved in evaluating the performance of multiband diagnostics and why traditional measures like sensitivity and specificity may not suffice.
4. Likelihood Ratios Over Sensitivity and Specificity: Grasp why likelihood ratios are a more appropriate statistical measure for multiband diagnostics and how they relate to pretest and posttest probabilities.
5. Clinical Relevance is Key: Recognize the importance of ensuring that the markers detected by IVDs are clinically meaningful and relevant to the condition being diagnosed.
6. FDA's Expectations for IVDs: Gain insights into the specific data and performance characteristics the FDA looks for in IVDs and the necessity of clinical data in regulatory submissions.

Quote:

"With IVDs, you're looking at it from the perspective of what's the risk of a false result or an inaccurate result. So you're looking at who's interpreting the results and the type of condition." ~Carmen Brown

Reference Links:

• Carmen Brown
• Proxima Clinical Research
• Greenlight Guru
• Etienne Nichols' LinkedIn

*Interested in sponsoring an episode? Use this form and let us know!