Hardware Podcasts

Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices

Global Medical Device Podcast · 21 Apr 2021 · 34m · Episode 198

What this episode covers

Milton Yarberry, Director of Medical Programs at Integrated Computer Solutions (ICS), joins host John Spear to discuss the regulatory and engineering distinctions between In Vitro Diagnostic (IVD) devices and traditional medical devices. They clarify that while IVDs are a subset of medical devices subject to similar quality systems (21 CFR Part 820, ISO 13485), their risk classification is based on the assay's impact rather than direct patient harm. The conversation highlights how IVD manufacturers often struggle with design controls because their background is in clinical science rather than commercial engineering, leading to a focus on analytical fidelity over user interface. They also address the evolving regulatory landscape, including CLIA Waiver requirements, the status of Lab Developed Tests (LDTs), and the impact of the EU MDR/IVDR and FDA Emergency Use Authorizations (EUA).

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Integrated Computer Solutions, Greenlight Guru, ICS
Also
CLIA, FDA, EU MDR, IVDR, EUA, 510(k), ISO 13485, IEC 62366

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