Medical Devices; Ophthalmic Devices; Classification of the Diurnal Pattern Recorder System
fda-device · Food and Drug Administration · Rule · Published 2016-05-31 · Effective 2016-05-31 · 81 FR 34269
Document
Document number
2016-12683
Federal Register citation
81 FR 34269
CFR reference
21 CFR 886
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2016-05-31
Effective date
2016-05-31
HHS docket
Docket No. FDA-2016-N-1268
Abstract
The Food and Drug Administration (FDA) is classifying the diurnal pattern recorder system 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 diurnal pattern recorder system'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.