# Microbiology Devices; Reclassification of Herpes Simplex Virus Types 1 and 2 Serological Assays
> **Food and Drug Administration** · Direct final rule. · Published 2009-08-25 · Effective 2009-12-07 · 74 FR 42773
## Document
- **Document number:** E9-20411
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 74 FR 42773
- **CFR reference:** 21 CFR 866
- **Publication date:** 2009-08-25
- **Effective date:** 2009-12-07
- **HHS docket:** Docket No. FDA-2009-N-0344
## Abstract

The Food and Drug Administration (FDA) is implementing a direct final rule correcting the regulation classifying herpes simplex virus (HSV) serological assays by removing the reference to HSV serological assays other than type 1 and type 2. When reclassifying this device, FDA mistakenly distinguished between HSV serological assays type 1 and type 2 and all other HSV serological assays. At that time, and today, the only preamendments HSV serological assays which FDA was aware of were type 1 and type 2 and, therefore, the classification of HSV assays other than type 1 and type 2 was incorrect. FDA is correcting the classification of this device to eliminate possible confusion resulting from this error. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedure for notice and comment to provide a procedural framework to finalize the rule in the event we receive significant adverse comment and withdraw this direct final rule.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2009/08/25/E9-20411/microbiology-devices-reclassification-of-herpes-simplex-virus-types-1-and-2-serological-assays)
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