# Microbiology Devices; Reclassification of Herpes Simplex Virus Types 1 and 2 Serological Assays
> **Food and Drug Administration** · Final rule. · Published 2007-04-03 · Effective 2007-05-03 · 72 FR 15828
## Document
- **Document number:** E7-6167
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 72 FR 15828
- **CFR reference:** 21 CFR 866
- **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."

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2007/04/03/E7-6167/microbiology-devices-reclassification-of-herpes-simplex-virus-types-1-and-2-serological-assays)
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