Laboratory Developed Test

Laboratory Developed Test (LDT) is a term used to refer to a certain class of in vitro diagnostics (IVDs). In the United States, the Food and Drug Administration (FDA) has determined that while such tests qualify as medical devices, FDA will allow these products to enter the market without prior approval from the Agency. On July 31, 2014, the FDA announced that it will start regulating some LDTs.^[1]

References

• FDA/CDRH Public Meeting: Oversight of Laboratory Developed Tests (LDTs), Date July 19-20, 2010