According to Emily Wasserman of Fierce Medical Devices, “FDA is calling for more oversight of lab-developed tests (LDTs)”. In a recent congressional hearing, FDA reviewed 20 case studies where certain LDTs “may have caused or have caused” harm to patients. With this information, it seems that the current Clinical Laboratory Improvement Amendments (CLIA) regulations for LDTs are not comprehensive enough and more regulatory attention is required to protect patient health.
To check out Wasserman’s article click here. Need help with mapping out your regulatory path for an LDT? Contact us at Pearl Pathways.