Children's Hospital Association commented on the FDA proposed rule that would require laboratory developed tests (LDTs) to be regulated as medical devices. CHA’s comments urged the FDA to continue enforcement discretion for pediatric-related tests that enable children with specialized health care needs to continue to get needed care.
LDTs fill a critical gap in the practice of pediatric medicine as they allow for accurate, timely, accessible, and high-quality testing for many pediatric conditions for which no commercial test exists or where an existing test does not meet current clinical needs.
