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# Class 2 for Health Risk Assessment Systems
- URL: https://www.fdaweb.com/class-2-for-health-risk-assessment-systems/
- Published: 2017-11-07T12:00:00.000Z
- Updated: 2026-09-14T23:00:34.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140067

*Federal Register* notice: FDA has classified genetic health risk assessment systems into Class 2 (special controls). The action was taken in response to a 2016 *de novo* request submitted by 23andMe for its Personal Genome Service Test. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-11-07/pdf/2017-24159.pdf?ref=fdaweb.com).