America’s Blood Centers strongly supports the Freedom for Laboratory Innovation and Testing Act. This legislation, introduced by Representatives Finstad and Crenshaw, aims to prevent federal funding from being used to implement the FDA’s new rule on Laboratory Developed Tests (LDTs). This letter highlights how blood centers already operate under a comprehensive regulatory framework, including FDA requirements, state-specific rules, and accreditation standards. In May 2024, the FDA issued a final rule subjecting in vitro diagnostic products to additional regulations, which are redundant and burdensome. These new regulations hinder patient care by causing delays and reducing test availability, particularly for LDTs crucial in urgent, life-saving situations. ABC thanks these Representatives for their efforts to prevent the implementation of this unnecessary and potentially harmful rule.
