Medical Devices; Immunology and Microbiology Devices; Classification of Dengue Virus Serological Reagents
fda-device · Food and Drug Administration · Rule · Published 2014-05-30 · Effective 2014-06-30 · 79 FR 31021
Document
Document number
2014-12545
Federal Register citation
79 FR 31021
CFR reference
21 CFR 866
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2014-05-30
Effective date
2014-06-30
HHS docket
Docket No. FDA-2014-N-0429
Abstract
The Food and Drug Administration (FDA) is classifying dengue virus serological reagents into class II (special controls). The special controls that will apply to the device are identified in this order, and the codified language for the dengue serological reagents classification will include the identification of the special controls that will apply to this device. The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.