U.S. FEDRegulation
FDA classifies hereditary cancer DNA sequencing test as class II device
The Food and Drug Administration classified the high throughput DNA sequencing for hereditary cancer predisposition assessment test system into class II with special controls. FDA determined that the class II classification will provide reasonable assurance of the device's safety and effectiveness. The agency said the action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens. The order is effective October 6, 2026; the classification was applicable September 29, 2023.
Key points
- High throughput DNA sequencing test for hereditary cancer predisposition assessment classified into class II.Federal Register
- Special controls identified in the order join the codified classification language.Federal Register
- FDA found class II will reasonably assure the device's safety and effectiveness.Federal Register
- Order effective October 6, 2026; classification applicable September 29, 2023.Federal Register
- The final order was published at 91 FR 63487 (FR Doc. 2026-20443).Federal Register
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RegulationU.S.FDA Final Order: Classification of High Throughput DNA Sequencing for Hereditary Cancer Predisposition Assessment Test System (Class II)HealthcareFor practitionersFor governance