Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological Reagents
fda-device · Food and Drug Administration · Rule · Published 2012-03-09 · Effective 2012-04-09 · 77 FR 14272
Document
Document number
2012-5675
Federal Register citation
77 FR 14272
CFR reference
21 CFR 866
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2012-03-09
Effective date
2012-04-09
HHS docket
Docket No. FDA-2012-N-0165
Abstract
The Food and Drug Administration (FDA) is classifying norovirus serological reagents into class II (special controls). The special control that will apply to these devices is the guidance document entitled "Class II Special Controls Guidance Document: Norovirus Serological Reagents." The Agency is classifying these devices into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices and there is sufficient information to establish special controls.