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# Class 2 for Recessive Carrier Screening Gene Mutation Detectors
- URL: https://www.fdaweb.com/class-2-for-recessive-carrier-screening-gene-mutation-detectors/
- Published: 2017-11-07T12:00:00.000Z
- Updated: 2026-09-14T23:00:27.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140069

*Federal Register* final order: FDA has exempted from premarket notification requirements autosomal recessive carrier screening gene mutation detection systems. The exemption is only applicable to prescription-only tests that have existing or reasonably foreseeable characteristics of commercially distributed devices within the generic type, and where a misdiagnosis would not be associated with high morbidity or mortality. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-11-07/pdf/2017-24162.pdf?ref=fdaweb.com).