Medical Devices; Gastroenterology-Urology Devices; Classification of the Magnetically Maneuvered Capsule Endoscopy System
fda-device · Food and Drug Administration · Rule · Published 2022-05-06 · Effective 2022-05-06 · 87 FR 26991
Document
Document number
2022-09735
Federal Register citation
87 FR 26991
CFR reference
21 CFR 876
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2022-05-06
Effective date
2022-05-06
HHS docket
Docket No. FDA-2022-N-0141
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the magnetically maneuvered capsule endoscopy 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 magnetically maneuvered capsule endoscopy 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.