Data / Federal rules / 2025-08148

Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Voriconazole Test System

The Food and Drug Administration published this final rule in the Federal Register on May 9, 2025. It took effect on May 9, 2025.

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What the agency says

The Food and Drug Administration (FDA, Agency, or we) is classifying the voriconazole test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the voriconazole test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Key facts

Document number: 2025-08148
Type: Final rule
Action: Final amendment; final order
Agency: Health and Human Services Department; Food and Drug Administration
Published: May 9, 2025
Takes effect: May 9, 2025
Dates: This order is effective May 9, 2025. The classification was applicable on May 5, 2017.
Docket: Docket No. FDA-2025-N-0780
Code of Federal Regulations: 21 CFR 862
Topics: Medical devices
Pages: 3

The document on federalregister.gov PDF

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Everything from the Food and Drug Administration · Rules on medical devices · Published in May 2025

Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.