Medical Devices; Neurological Devices; Classification of the External Vagal Nerve Stimulator for Headache
fda-device · Food and Drug Administration · Rule · Published 2017-12-27 · Effective 2017-12-27 · 82 FR 61168
Document
Document number
2017-27854
Federal Register citation
82 FR 61168
CFR reference
21 CFR 882
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2017-12-27
Effective date
2017-12-27
HHS docket
Docket No. FDA-2017-N-6531
Abstract
The Food and Drug Administration (FDA or we) is classifying the external vagal nerve stimulator for headache 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 external vagal nerve stimulator for headache'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, in part by reducing regulatory burdens.