Although the U.S. Cystic Fibrosis Foundation Patient Registry (CFFPR) collects data regarding the use of CFTR modulators, it does not collect data on infants born to mothers of CF; thus, it is not possible to determine from the U.S. CFFPR [3] the rate of congenital malformations in infants born to women with CF in general nor the rate of congenital malformation in infants in association with CFTR modulator use. This evidence concerns the gene CFTR and cystic fibrosis.