Medical Devices; General Hospital and Personal Use Devices; Classification of the Intravenous Catheter Force-Activated Separation Device
fda-device · Food and Drug Administration · Rule · Published 2024-08-16 · Effective 2024-08-16 · 89 FR 66558
Document
Document number
2024-18267
Federal Register citation
89 FR 66558
CFR reference
21 CFR 880
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2024-08-16
Effective date
2024-08-16
HHS docket
Docket No. FDA-2024-N-3356
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the intravenous catheter force-activated separation device 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 intravenous catheter force-activated separation device'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.