> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Proposal to Classify Certain Antigen Devices in Class 2
- URL: https://www.fdaweb.com/proposal-to-classify-certain-antigen-devices-in-class-2/
- Published: 2022-01-20T12:00:00.000Z
- Updated: 2026-09-14T17:29:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150962

*Federal Register* notice: FDA is seeking comments on its proposal to classify human leukocyte antigen, human platelet antigen, and human neutrophil antigen devices into Class 2 (special controls). The agency says it does not intend to exempt these device types from premarket notification requirements. After considering comments, FDA will publish a final regulation classifying the device types. To view the notice, click [here](https://public-inspection.federalregister.gov/2022-01156.pdf?ref=fdaweb.com).