21 CFR 866.6040
§ 866.6040 Gene expression profiling test system for breast cancer prognosis.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 866.6040, § 866.6040 Gene expression profiling test system for breast cancer prognosis, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89693
- Permanent ID
ys:prov:89693@1- SHA-256
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.