Letter to the Office of Information and Regulatory Affairs RE: establishing a regulatory framework for lab-developed tests
![A CDC scientist unpacking testing kits](/sites/default/files/styles/700x530/public/2023-09/cdc-YlES0PvDgyc-unsplash.jpg?h=7d43f243)
CDC.
LDTs have become increasingly important in clinical practice but put patients at risk and increase healthcare costs when they are inaccurate or are not supported by scientific evidence
CSPI supports the efforts by the FDA to regulate LDTs, as a modern regulatory framework will improve patient access to reliable tests.