The idea was that whether a laboratory test for a given disease was an IVD or LDT, it would (i) need to meet similar standards with regard to analytical and clinical validity and performance ...

The US Food and Drug Administration (FDA) has issued its Final Rule in officially making explicit that In Vitro diagnostic products (IVD), also known as laboratory-developed tests (LDT), are ...

On May 6, 2024, FDA issued the LDT Final Rule amending FDA’s regulations to make explicit that IVDs are medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including when ...

defined as in vitro diagnostics (IVD) products – as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). Filed by the American Clinical Laboratory Association (ACLA), member ...

The agency could continue to pursue more extensive LDT oversight by tightening control over items like RUO reagents and specimen collection devices.

has submitted a validation package to the New York State Department of Health or NYSDOH to request approval as a laboratory-developed test LDT for a PCR-based assay for the detection and subtyping ...

Following the LDT process in the US. It is under CE-IVD marking for use in Europe. About Gestalt : Gestalt Diagnostics transforms pathology through an intelligent, configurable, vendor-neutral ...

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 ...

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