The Food and Drug Administration classified the high-throughput DNA sequencing for hereditary cancer predisposition assessment test system into Class II with special controls on October 5, 2026. The agency determined that this classification provides reasonable assurance of safety and effectiveness for the device.

The FDA stated the action will enhance patient access to beneficial innovative devices by reducing regulatory burdens. This regulatory pathway allows for the marketing of novel medical devices that are low to moderate risk and for which general controls alone do not provide reasonable assurance of safety and effectiveness.

The device is a qualitative in vitro diagnostic system intended to detect germline mutations in targeted cancer-related genes. It is not intended for screening, prenatal testing, or as a stand-alone diagnostic test. The classification establishes specific performance standards to ensure the reliability of genetic testing results used in clinical decision-making.

Special controls mandate rigorous testing protocols for variant detection. For BRCA1 and BRCA2 genes, a minimum of 120 variant-positive specimens must be tested. For other genes with high clinical significance, at least 40 variant-positive specimens must be tested per gene. These requirements ensure that the system can accurately identify mutations across a broad range of clinically relevant targets.

Accuracy and precision thresholds are strictly defined under the special controls. Overall accuracy for reporting of substitutions must be greater than or equal to 99.0 percent. Overall accuracy for copy number variations must be greater than or equal to 99.9 percent for negative agreement.

The overall precision point estimates for each variant type must be greater than 99.0 percent. These metrics serve as benchmarks for manufacturers seeking to market similar systems.

The regulatory framework for such devices has evolved through legislative changes. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo classification process by adding a second procedure. The FDA may classify a device through De Novo classification under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act.

Why It Matters

This classification fits within a documented pattern of regulatory actions for genomic testing technologies. The FDA previously classified whole exome sequencing constituent devices as Class II with special controls in 2024, establishing a precedent for similar genomic testing technologies under the De Novo pathway. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first De Novo classification procedure, which was used in 2013 to classify the Illumina MiSeqDx Platform as a Class II device for clinical genomic sequencing.

The procedural framework continues to adapt to new testing methodologies. Section 607 of the Food and Drug Administration Safety and Innovation Act (2012) expanded the De Novo pathway by allowing direct submissions without prior 510(k) clearance, a process used in the 2025 classification of the DNA-based minimal residual disease test. The De Novo classification process requires the FDA to issue a written order within 120 days of a request, as outlined in the 2025 classification of the inherited nucleotide repeat disorder DNA test, which was finalized under this procedural framework.

Timeline

Devices not in commercial distribution before May 28, 1976, are automatically classified into Class III and require premarket approval unless the FDA takes action to classify or reclassify them. The classification was applicable on September 29, 2023. On October 5, 2026, the Food and Drug Administration classified the high-throughput DNA sequencing for hereditary cancer predisposition assessment test system into Class II with special controls.

On the same date, October 5, 2026, the Food and Drug Administration stated the action will enhance patient access to beneficial innovative devices by reducing regulatory burdens. Also on October 5, 2026, the Food and Drug Administration determined that classifying the device into Class II provides reasonable assurance of safety and effectiveness.

What's New

Additional context shows the historical application of these regulatory pathways.

Further details describe the expansion of submission options.