Medical Devices; Neurological Devices; Classification of the Thermal System for Insomnia
fda-device · Food and Drug Administration · Rule · Published 2016-07-11 · Effective 2016-07-11 · 81 FR 44771
Document
Document number
2016-16351
Federal Register citation
81 FR 44771
CFR reference
21 CFR 882
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2016-07-11
Effective date
2016-07-11
HHS docket
Docket No. FDA-2016-N-1653
Abstract
The Food and Drug Administration (FDA) is classifying the thermal system for insomnia into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the thermal system for insomnia's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.