Assurentry Team · February 2026
What Are IVDs?
In vitro diagnostic (IVD) devices are products intended to diagnose disease or conditions using specimens from the human body. They range from Class I (low risk) to Class III (high risk) and include tests for infectious disease, cancer, and genetics.
FDA Oversight of IVDs
FDA regulates IVDs as medical devices. Premarket pathways include 510(k), De Novo, and PMA. Laboratory-developed tests (LDTs) have been under increasing FDA scrutiny—see LDT phaseout for current policy.
Classification and Pathways
Most IVDs are Class II and require 510(k) clearance. High-risk IVDs need PMA. De Novo may apply to novel devices of low to moderate risk. Performance studies and analytical validation are typically required.
IVD regulatory support
Assurentry helps IVD manufacturers navigate FDA clearance and compliance.
Get IVD HelpQuality Systems and Labeling
IVD manufacturers must comply with QSR/QMSR, design controls, and risk management. Labeling must include intended use, instructions for use, and performance claims. Validation and verification are essential.
Registration and Postmarket
Register establishment and list devices. UDI applies. MDR reporting, recalls, and corrections follow standard device requirements. Stay current on FDA guidance for IVDs and related policy.
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