Microbiology Devices; Reclassification of Herpes Simplex Virus Types 1 and 2 Serological Assays
fda-device · Food and Drug Administration · Rule · Published 2007-04-03 · Effective 2007-05-03 · 72 FR 15828
Document
Document number
E7-6167
Federal Register citation
72 FR 15828
CFR reference
21 CFR 866
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2007-04-03
Effective date
2007-05-03
HHS docket
Docket No. 2005N-0471
Abstract
The Food and Drug Administration (FDA) is reclassifying herpes simplex virus (HSV) types 1 and/or 2 (HSV 1 and 2) serological assays from class III (premarket approval) to class II (special controls). FDA had earlier proposed this reclassification on its own initiative based on new information. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a class II special controls guidance entitled "Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays."