Medical Devices; General Hospital and Personal Use Devices; Classification of the Ultraviolet Radiation Chamber Disinfection Device
fda-device · Food and Drug Administration · Rule · Published 2015-11-20 · Effective 2015-11-20 · 80 FR 72587
Document
Document number
2015-29660
Federal Register citation
80 FR 72587
CFR reference
21 CFR 880
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2015-11-20
Effective date
2015-11-20
HHS docket
Docket No. FDA-2015-N-3838
Abstract
The Food and Drug Administration (FDA or the Agency) is classifying the ultraviolet (UV) radiation chamber disinfection 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 UV radiation chamber disinfection device 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.