Medical Devices; Anesthesiology Devices; Classification of the Isocapnic Ventilation Device
fda-device · Food and Drug Administration · Rule · Published 2021-12-02 · Effective 2021-12-02 · 86 FR 68396
Document
Document number
2021-26201
Federal Register citation
86 FR 68396
CFR reference
21 CFR 868
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2021-12-02
Effective date
2021-12-02
HHS docket
Docket No. FDA-2021-N-0622
Abstract
The Food and Drug Administration (FDA or we) is classifying the isocapnic ventilation 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 isocapnic ventilation 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.