Microbiology Devices; Reclassification of Hepatitis A Virus Serological Assays; Correction
fda-device · Food and Drug Administration · Rule · Published 2006-03-01 · Effective 2006-03-13 · 71 FR 10433
Document
Document number
06-1871
Federal Register citation
71 FR 10433
CFR reference
21 CFR 866
Type
Rule
Action
Final rule; correction.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2006-03-01
Effective date
2006-03-13
HHS docket
Docket No. 2003P-0564
Abstract
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of February 9, 2006 (71 FR 6677). That document reclassified hepatitis A virus (HAV) serological assays from class III (premarket approval) into class II (special controls). That document inadvertently published with an error. This document corrects the error.