> ## 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.

# Whole Exome Sequencing Devices are Class 2
- URL: https://www.fdaweb.com/whole-exome-sequencing-devices-are-class-2/
- Published: 2024-09-10T12:00:00.000Z
- Updated: 2026-09-14T14:40:46.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157744

*Federal Register* notice: FDA is classifying whole exome sequencing devices into Class 2 (special controls). The move follows a 2019 request from Helix OpCo for the de novo classification of its Helix Learning Platform, which is used for analyzing the complete coding region of an individual’s DNA. The DNA sequence generated is intended as input for clinical germline DNA assays that have an FDA marketing authorization. To view the notice, click [here](https://public-inspection.federalregister.gov/2024-20550.pdf?ref=fdaweb.com).