---
kind: "section"
citation: "21 C.F.R. § 866.6040"
title: "21"
number: "866.6040"
heading: "Gene expression profiling test system for breast cancer prognosis."
url: "https://uscodex.org/cfr/21/866.6040"
---

# §866.6040. Gene expression profiling test system for breast cancer prognosis.

- (a) **Identification.** A gene expression profiling test system for breast cancer prognosis is a device that measures the ribonucleic acid (RNA) expression level of multiple genes and combines this information to yield a signature (pattern or classifier or index) to aid in prognosis of previously diagnosed breast cancer.
- (b) **Classification.** Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis.” See [§ 866.1(e)](/cfr/21/866.1.md?p=e) for the availability of this guidance document.

## Notes

### Amendments

[72 FR 26291, May 9, 2007]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 47 FR 50823, Nov. 9, 1982, unless otherwise noted.

### Amendments

[72 FR 26291, May 9, 2007]