Hardware Podcasts

#348: Considerations for IVD

Global Medical Device Podcast · 14 Dec 2023 · 36m · Episode 348

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Proxima Clinical Research, 23andMe, Greenlight Guru
Also
FDA, CDRH, CBER

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