.jpg)
FDA’s LDT rule struck down in Texas court
A Texas judge has ruled against the US Food and Drug Administration (FDA) in a court case that challenged the agency’s plans to regulate laboratory-developed tests (LDTs) – defined as in vitro diagnostics (IVD) products – as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). The post FDA’s LDT rule struck down in Texas court appeared first on Medical Device Network.
A Texas judge has ruled against the US Food and Drug Administration (FDA) in a court case that challenged the agency’s plans to regulate laboratory-developed tests (LDTs) – defined as in vitro diagnostics (IVD) products – as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).
The post FDA’s LDT rule struck down in Texas court appeared first on Medical Device Network.
