Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingested, Transient, Space Occupying Device for Weight Management and/or Weight Loss
fda-device · Food and Drug Administration · Rule · Published 2021-12-10 · Effective 2021-12-10 · 86 FR 70371
Document
Document number
2021-26738
Federal Register citation
86 FR 70371
CFR reference
21 CFR 876
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2021-12-10
Effective date
2021-12-10
HHS docket
Docket No. FDA-2021-N-0585
Abstract
The Food and Drug Administration (FDA or we) is classifying the ingested, transient, space occupying device for weight management and/or weight loss 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 ingested, transient, space occupying device for weight management and/or weight loss'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.