Statement from The Coalition for 21st Century Medicine Regarding the FDA’s Final Rule for Regulating Lab-Developed Tests as Medical Devices
The Food and Drug Administration (FDA) announced on April 29, 2024 that it intends to regulate Laboratory Developed Tests (LDTs) furnished by clinical laboratories as medical devices. C21 has long been concerned that applying FDA regulatory requirements designed for distributed medical devices to laboratory procedures will hinder patient access to critical LDTs that are the leading edge of advancing precision medicine in patient care.
“Advanced genomic diagnostics are key to realizing the promise of Precision Medicine. By enabling smarter, more targeted and more personalized medicine, we can improve patient outcomes and reduce the use of healthcare resources. To achieve this potential, we must ensure regulatory, reimbursement and legal frameworks that recognize the value of our tests and encourage continued innovation and investment in this important field.” — Bonnie Anderson, Board Member and Co-Founder, Veracyte
