Healthcare Providers and medical device manufacturers alike are working diligently to ensure that their services and products are compliant with these new regulations in the medical device industry in the European Union (EU).
Learn more about the practice of newborn screening as we unravel the science behind it in our monthly Renata Newborn Screening Podcast series.
Don Mason reviews the state of newborn screening (NBS) programs around the world.
Newborn screening for inherited metabolic disorders dates to the early 1960s when Dr. Robert Guthrie in Buffalo, New York developed the first screening test for phenylketonuria (or PKU), a metabolic disease in which patients can’t metabolize the amino acid phenylalanine.
U.S. FDA Prepares to Oversee LDTs Recently, the U.S. Food and Drug Administration’s Office of Public Health Strategy and Analysis issued an interesting (and much anticipated) report regarding Laboratory Developed Tests (LDTs). The Agency has… Read more >