FDA Classifies Newborn Screening Test Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry

Summary

The Food and Drug Administration (FDA) has classified newborn screening test systems for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry into Class II, requiring special controls to ensure the devices meet safety and effectiveness standards, in response to a petition under the Federal Food, Drug, and Cosmetic Act.