The 903 paper, an FDA-registered in vitro Class II medical device, is used in virtually all US newborn screening programs and in most newborn screening programs throughout the world. Widespread testing for phenylketonuria (PKU) has led to early detection and intervention for tens of thousands of babies worldwide. Newborn screening programs today screen for, depending on the state or country, anywhere from three to eleven or more analytes, including congenital hypothyroidism, galactosemia, branched-chain ketonuria, maple sugar urine disorder and sickle-cell anemia. More recently, with the advent of tandem mass spectrometry technology, many programs are adding less frequently occurring disorders to their panel of analytes, including MCAD, cystic fibrosis and a range of amino acid disorder