21 CFR § 866.6040 - Gene expression profiling test system for breast cancer prognosis.

---
identifier: "/us/cfr/t21/s866.6040"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.6040 - Gene expression profiling test system for breast cancer prognosis."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.6040"
section_name: "Gene expression profiling test system for breast cancer prognosis."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "866"
part_name: "IMMUNOLOGY AND MICROBIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "47 FR 50823, Nov. 9, 1982, unless otherwise noted."
cfr_part: "866"
---


# 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) for the availability of this guidance document.

[72 FR 26291, May 9, 2007]