Code of Federal Regulations Title 21. Food and Drugs § 21.866.5900 Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system

(a) Identification. The CFTR gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the CFTR gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), carrier identification, and newborn screening. This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic, pre-implantation, or population screening.

(b) Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document:  CFTR Gene Mutation Detection System.” See § 866.1(e) for the availability of this guidance document.