IVDs include immunoassays, molecular diagnostics (PCR, NGS), clinical chemistry, hematology, microbiology, and point-of-care tests. Regulated by FDA's CDRH (CBER for some) and under the EU IVDR in Europe. IVDs are regulated by FDA under device rules, while laboratories using them are certified under CLIA. In the EU, the IVDR uses a risk-based classification from Class A to D. Clinical validity and analytical performance data are central to approval.

Why it matters

Roche Diagnostics, Abbott, Siemens Healthineers, Danaher (Beckman, Cepheid), and Thermo Fisher dominate. Companion diagnostics and oncology MRD are key growth areas. EU IVDR transition has been disruptive.

Common pitfalls

•A common pitfall is misunderstanding the classification rules for IVDs, which can lead to incorrect conformity assessment routes and delays in market access.
•Failing to adequately validate software used in IVDs can result in regulatory non-compliance, as software is considered a medical device or an accessory to one.
•Ignoring post-market surveillance requirements for IVDs can lead to significant regulatory issues, especially under the EU IVDR's emphasis on lifelong monitoring.
•Confusion surrounding companion diagnostics, specifically their dual regulation as both pharmaceuticals and medical devices, can lead to compliance gaps.

Sources

AdvaMedDx · AdvaMedDx
MedTech Dive · MedTech Dive
AdvaMed - Industry Reports · AdvaMed
In vitro diagnostics · U.S. Food and Drug Administration (FDA)

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
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Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

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