§ 862.3360. Drug metabolizing enzyme genotyping system.
112 words·~1 min read·
/us/cfr/t21/s§ 862.3360·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A drug metabolizing enzyme genotyping system is a device intended for use in testing deoxyribonucleic acid
(DNA)extracted from clinical samples to identify the presence or absence of human genotypic markers encoding a drug metabolizing enzyme. This device is used as an aid in determining treatment choice and individualizing treatment dose for therapeutics that are metabolized primarily by the specific enzyme about which the system provides genotypic information.
(b)Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping Test System.” See § 862.1(d) for the availability of this guidance document. [70 FR 11867, Mar. 10, 2005]
Connections1 cite this
Cited by 1 section
register
Citation graph
cites case law
§ 862.3360
Drug metabolizing enzyme genotyping system.
Fed. Reg.×1
Cites 0Cited by 1 across 1 source