Medical Devices; General and Plastic Surgery Devices; Classification of the Carbon Dioxide Gas Controlled Tissue Expander
fda-device · Food and Drug Administration · Rule · Published 2022-02-04 · Effective 2022-02-04 · 87 FR 6419
Document
Document number
2022-02357
Federal Register citation
87 FR 6419
CFR reference
21 CFR 878
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2022-02-04
Effective date
2022-02-04
HHS docket
Docket No. FDA-2021-N-0948
Abstract
The Food and Drug Administration (FDA or we) is classifying the carbon dioxide gas controlled tissue expander 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 carbon dioxide gas controlled tissue expander'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.