This one pager outlines the implications of the FDA’s May 2024 final rule on in vitro diagnostic products (IVDs), focusing on its impact on blood centers and laboratory developed tests (LDTs). It provides an overview of the current regulatory framework for blood centers, explains the critical role of LDTs in life-saving procedures, and highlights concerns about the new regulation’s potential to delay patient care and increase costs. It also includes the need for exempting blood center LDTs from new regulatory reforms, including highlighting Congressional reservations about the FDA’s authority. It serves as a comprehensive brief for healthcare professionals, policymakers, and stakeholders interested in understanding the potential consequences of this regulatory change on blood center operations and patient care across America.
