Medical Devices; Gastroenterology-Urology Devices; Classification of the Hemodialyzer With Expanded Solute Removal Profile
fda-device · Food and Drug Administration · Rule · Published 2024-09-06 · Effective 2024-09-06 · 89 FR 72715
Document
Document number
2024-20081
Federal Register citation
89 FR 72715
CFR reference
21 CFR 876
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2024-09-06
Effective date
2024-09-06
HHS docket
Docket No. FDA-2024-N-3972
Abstract
The Food and Drug Administration (FDA or we) is classifying the hemodialyzer with expanded solute removal profile 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 hemodialyzer with expanded solute removal profile'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.