Data / Federal rules / 2025-08151

Medical Devices; Hematology and Pathology Devices; Classification of the Coagulation System for the Measurement of Whole Blood Viscoelastic Properties in Perioperative Patients

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 coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients 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 coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients' 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: 2025-08151
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 March 12, 2019.
Docket: Docket No. FDA-2025-N-0711
Code of Federal Regulations: 21 CFR 864
Topics: Blood; Medical devices; Packaging and containers
Pages: 3

The document on federalregister.gov PDF

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

Read from the Federal Register API, last updated 2026-10-24. 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.