Medical Devices; Neurological Devices; Classification of the Evoked Photon Image Capture Device
fda-device · Food and Drug Administration · Rule · Published 2016-09-30 · Effective 2016-09-30 · 81 FR 67154
Document
Document number
2016-23633
Federal Register citation
81 FR 67154
CFR reference
21 CFR 882
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2016-09-30
Effective date
2016-09-30
HHS docket
Docket No. FDA 2016-N-2677
Abstract
The Food and Drug Administration (FDA) is classifying the Evoked Photon Image Capture Device into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device.