Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological Reagents; Correction
fda-device · Food and Drug Administration · Rule · Published 2012-04-02 · Effective 2012-04-09 · 77 FR 19534
Document
Document number
2012-7757
Federal Register citation
77 FR 19534
CFR reference
21 CFR 866
Type
Rule
Action
Final rule; correction.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2012-04-02
Effective date
2012-04-09
HHS docket
Docket No. FDA-2012-N-0165
Abstract
In the Federal Register of March 9, 2012 (76 FR 14272), the Food and Drug Administration (FDA) classified norovirus serological reagents 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. The document published with inadvertent errors in the Analysis of Impacts section. This document corrects those errors.