Medical Devices; Neurological Devices; Classification of Repetitive Transcranial Magnetic Stimulation System
fda-device · Food and Drug Administration · Rule · Published 2011-07-26 · Effective 2011-08-25 · 76 FR 44489
Document
Document number
2011-18806
Federal Register citation
76 FR 44489
CFR reference
21 CFR 882
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2011-07-26
Effective date
2011-08-25
HHS docket
Docket No. FDA-2011-N-0466
Abstract
The Food and Drug Administration (FDA) is classifying the repetitive transcranial magnetic stimulation (rTMS) system into class II (special controls). The Agency is classifying this device type into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.