CHA submitted a statement for the record for the Energy and Commerce Health Subcommittee hearing on “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.”
The hearing focused on the FDA proposed rule to regulation laboratory developed tests (LDTs). Our statement emphasizes the critical and unique role that LDTs play in pediatric health care and expresses concerns about the rule’s negative impact children’s access to life-saving tests and timely care.
