⚙️FDA Classifies Coagulation System for Blood Measurement Devices
Medical Devices; Hematology and Pathology Devices; Classification of the Coagulation System for the Measurement of Whole Blood Viscoelastic Properties in Perioperative Patients
Summary
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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's classification of the coagulation system for measuring blood viscoelastic properties as Class II (special controls) affects regulatory requirements for manufacturers. This class reduces the burdens associated with premarket approval, enabling easier market access and potential financial implications for device companies.