Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Clozapine Test System
fda-device · Food and Drug Administration · Rule · Published 2024-09-16 · Effective 2024-09-16 · 89 FR 75489
Document
Document number
2024-20895
Federal Register citation
89 FR 75489
CFR reference
21 CFR 862
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2024-09-16
Effective date
2024-09-16
HHS docket
Docket No. FDA-2024-N-4058
Abstract
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.