Medical Devices; Neurological Devices; Classification of Cranial Motion Measurement Device
fda-device · Food and Drug Administration · Rule · Published 2017-07-28 · Effective 2017-07-28 · 82 FR 35069
Document
Document number
2017-15895
Federal Register citation
82 FR 35069
CFR reference
21 CFR 882
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2017-07-28
Effective date
2017-07-28
HHS docket
Docket No. FDA-2017-N-1608
Abstract
The Food and Drug Administration (FDA or Agency) is classifying the cranial motion measurement device 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 cranial motion measurement device'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.