FEATURE
Public health laboratories have long relied on laboratory-developed tests ( LDTs ) to meet emerging and other public health needs . LDTs enable flexible , nimble responses to needs in large and small geographic regions and in specific populations . These tests play a critical role in disease surveillance , outbreaks , newborn screening and environmental exposures , as well as in developing disease treatment and prevention guidelines and in promoting health equity .
Yet the continued and future use of LDTs in public health laboratories is now uncertain . On May 6 , 2024 , the US Food and Drug Administration ( FDA ) published its Final Rule : Medical Devices ; Laboratory Developed Tests . This rule adds FDA oversight to the creation and use of LDTs , classifying in vitro diagnostic products as medical devices under the Federal Food , Drug , and Cosmetic Act — including when the manufacturer of the IVD is a laboratory .
PublicHealthLabs
Spring 2025
@ APHL . org APHL . org
LAB MATTERS 11