FDA Regulation of LDTs is Misguided; Requires Congressional Authorization Washington, D.C. – The American Clinical Laboratory Association (ACLA) today submitted comments urging the U.S. Food … Read More

The post FDA Proposed Rule to Regulate LDTs as Medical Devices Would Slow Development of Critical Lab Tests and Should be Withdrawn, ACLA Urges appeared first on American Clinical Laboratory Association.

The post ACLA’s Comments on FDA’s Proposed Regulation of Laboratory Developed Tests as Medical Devices appeared first on American Clinical Laboratory Association.