Medical Devices; Gastroenterology-Urology Devices; Classification of the Esophageal Tissue Characterization System
fda-device · Food and Drug Administration · Rule · Published 2021-12-02 · Effective 2021-12-02 · 86 FR 68398
Document
Document number
2021-26200
Federal Register citation
86 FR 68398
CFR reference
21 CFR 876
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-0285
Abstract
The Food and Drug Administration (FDA or we) is classifying the esophageal tissue characterization 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 esophageal tissue characterization 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.