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# Next Gen Sequencing Tumor Profiling Test in Class 2
- URL: https://www.fdaweb.com/next-gen-sequencing-tumor-profiling-test-in-class-2/
- Published: 2018-06-22T12:00:00.000Z
- Updated: 2026-09-15T00:15:22.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141750

*Federal Register* notice: FDA has classified the next-generation sequencing-based tumor profiling test into Class 2 (special controls). The action is in response to a 2017 Memorial Sloan-Kettering Cancer Center Department of Pathology *de novo* classification request for its MSK–IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets). In classifying the device, the agency has defined such tests as qualitative *in vitro* diagnostic tests intended for NGS analysis of tissue specimens from malignant solid neoplasms to detect somatic mutations in a broad panel of targeted genes to aid in the management of previously diagnosed cancer patients by qualified health care professionals. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-06-22/pdf/2018-13406.pdf?ref=fdaweb.com).