Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Clozapine Test System
Information
Type
Rule
Regulated products
Medical Devices
Published
September 16, 2024
Last updated
September 16, 2024
Description
Document number 2024-20895. The Food and Drug Administration (FDA, Agency, or we) is classifying the clozapine 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 clozapine 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)