Hi,
Can a CLIA clinical lab create an LDT by obtaining a protocol for a test developed as an LDT by another facility? We found this documented in a few references online for example the one below, but fail to understand how would you satisfy FDA's requirement of LDTs as designed, developed and manufactured within a single lab.
www.pewtrusts.org
Thank you
Can a CLIA clinical lab create an LDT by obtaining a protocol for a test developed as an LDT by another facility? We found this documented in a few references online for example the one below, but fail to understand how would you satisfy FDA's requirement of LDTs as designed, developed and manufactured within a single lab.
The Role of Lab-Developed Tests in the In Vitro Diagnostics Market
In vitro diagnostic (IVD) tests—which use blood, saliva, and other human samples to detect the presence or risk of certain diseases—are a pillar of modern medicine.
Thank you
