Medical DevicesLast reviewed April 2026

In Vitro Diagnostic(IVD)

A medical device used to perform tests on samples taken from the human body to detect diseases, conditions, or infections.

Usage Examples

The IVD was filed as a 510(k) based on substantial equivalence to a cleared predicate.
IVDR Class C classification required notified body review of the performance evaluation.

What is IVD?

In Vitro Diagnostics (IVDs) are regulated medical devices that test samples (blood, urine, tissue) outside the body. In the US, IVDs are regulated by CDRH and classified per 21 CFR Part 809 and the relevant device regulation. In the EU, IVDs are regulated under the IVDR (Regulation (EU) 2017/746), which replaced the older IVDD with risk-based classification (Classes A, B, C, D).

FDA IVD submissions use the same pathways as other devices (510(k), De Novo, PMA) plus specific pathways for Laboratory Developed Tests (LDTs) following FDA's 2024 final rule. Companion diagnostics — IVDs paired with specific therapeutics — require coordinated review with the corresponding drug or biologic. EU IVDR classification drives notified body involvement and performance evaluation rigor.

Regulatory Context

This term appears most often in medical devices workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 809, IVDR 2017 746, FDCA.

FDA CDRHEMAHealth Canada

When This Matters

The IVD was filed as a 510(k) based on substantial equivalence to a cleared predicate.
IVDR Class C classification required notified body review of the performance evaluation.

Common Mistakes

Using drug-only submission assumptions for device regulatory pathways.
Ignoring post-market obligations in pre-market planning.
Weak predicate and classification rationale in dossier narratives.

Related Regulations

21 CFR 809IVDR 2017 746FDCA

Frequently Asked Questions

The US regulates IVDs under the same general device framework with IVD-specific requirements in 21 CFR 809. EU IVDR provides a distinct risk-based framework separate from MDR. Classification and pathway selection differ per region.

An IVD essential to the safe and effective use of a corresponding therapeutic. FDA reviews CDx alongside the companion drug or biologic. Labels for both products cross-reference each other.

Yes for Classes B, C, and D. Class A IVDs can be self-declared. The transition from IVDD created a backlog of IVDR certifications; sponsors should plan notified body engagement 12-18 months ahead.