Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss
fda-device · Food and Drug Administration · Rule · Published 2017-10-30 · Effective 2017-10-30 · 82 FR 50080
Document
Document number
2017-23490
Federal Register citation
82 FR 50080
CFR reference
21 CFR 876
Type
Rule
Action
Final order; correction.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2017-10-30
Effective date
2017-10-30
HHS docket
Docket No. FDA-2017-N-1609
Abstract
The Food and Drug Administration (FDA) is correcting a final order entitled "Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss" that appeared in the Federal Register of July 28, 2017. The final order was published with an incorrect statement in the preamble about whether FDA planned to exempt the device from premarket notification requirements. This document corrects that error.