Medical Devices; Gastroenterology-Urology Devices; Classification of the Gastrointestinal Lesion Software Detection System
fda-device · Food and Drug Administration · Rule · Published 2023-01-03 · Effective 2023-01-03 · 88 FR 8
Document
Document number
2022-28494
Federal Register citation
88 FR 8
CFR reference
21 CFR 876
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2023-01-03
Effective date
2023-01-03
HHS docket
Docket No. FDA-2022-N-3207
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the gastrointestinal lesion software detection 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 gastrointestinal lesion software detection 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.