# #348: Considerations for IVD

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-12-14
- Length: 36m
- Episode: 348
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-12-14-348-considerations-for-ivd
- Listen: https://podcast.greenlight.guru/episode/348-considerations-for-ivd

## Summary

Carmen Brown, regulatory and quality affairs manager at Proxima Clinical Research, explains the specific regulatory pathways for In Vitro Diagnostics (IVDs) under the FDA's CDRH. She details how IVD risk classification (Class 1, 2, or 3) depends on the consequences of false results, using examples like glucose monitors versus cancer diagnostics. Brown highlights common pitfalls in performance evaluation, particularly for multi-band diagnostics, arguing that likelihood ratios are superior to sensitivity and specificity for determining clinical utility. She also warns against the strategy of starting with Laboratory Developed Tests (LDTs) before pursuing full IVD approval, citing enforcement actions against companies like 23andMe as cautionary tales.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-12-14-348-considerations-for-ivd#t=0) Introduction: Carmen Brown and Proxima Clinical Research
- [3:35](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-12-14-348-considerations-for-ivd#t=215) Defining IVDs and FDA Risk Classification
- [6:22](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-12-14-348-considerations-for-ivd#t=382) Aid-to-Diagnosis vs. True Diagnostics
- [10:49](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-12-14-348-considerations-for-ivd#t=649) Performance Pitfalls: Multi-band Diagnostics and Likelihood Ratios
- [20:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-12-14-348-considerations-for-ivd#t=1245) Clinical Relevance and Surrogate Samples
- [24:18](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-12-14-348-considerations-for-ivd#t=1458) LDTs, Labeling, and the End of EUAs
- [27:20](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-12-14-348-considerations-for-ivd#t=1640) The LDT-to-IVD Pathway Failure and 23andMe Example
- [31:52](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-12-14-348-considerations-for-ivd#t=1912) CDRH vs. CBER and Combination Products

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

early-stage companies

## Mentioned

- Proxima Clinical Research (company)
- FDA (other)
- CDRH (other)
- CBER (other)
- 23andMe (company)
- Greenlight Guru (company)

## Related episodes from other shows

- [154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-18-154-ivds-ldts-companion-diagnostics-precision-medicine-clinical-validation-bioma) (Let's Combinate)
- [055 - "Critical Tasks and Knowledge Tasks" with Alexandra Benbadis](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-19-055-critical-tasks-and-knowledge-tasks-with-alexandra-benbadis) (Let's Combinate)
- [202 - Becoming an Expert in the Work Nobody Wants to Do/Design, Risk, and the Messy Middle of Combination Products w/Joey Frechin](https://hardwarepodcasts.com/podcast/lets-combinate/2025-08-20-202-becoming-an-expert-in-the-work-nobody-wants-to-do-design-risk-and-the-messy) (Let's Combinate)
- [079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-05-079-how-fda-reviews-combination-products-policy-eprs-and-harmonization-with-rumi) (Let's Combinate)
- [012 - "Asking then Seeing" with Sara Waxberg Mcnew](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-12-14-348-considerations-for-ivd. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.