Last month, the US Food and Drug Administration (FDA) announced it would soon seek to regulate lab-developed tests more similarly to in vitro diagnostics (IVDs), citing the devices' increasing ...
The US Food and Drug Administration (FDA) plans to hold a meeting to collect public feedback on a controversial proposal to revoke a longstanding regulatory exemption for lab-developed tests (LDTs) ...
FDA’s Authority Over Lab-Developed Tests Overturned: What the Court’s Decision Means for Lab Testing
Previously, this blog covered the FDA’s decision to regulate lab-developed tests (LDTs) as medical devices. However, a ruling from a federal district court in Texas earlier this year has changed that.
The U.S. Food and Drug Administration (FDA) plans to rescind its laboratory developed test (LDT) rule dated May 6, 2024. The rule would have regulated LDTs as in vitro diagnostic products (IVDs) and ...
The FDA has scrapped a rule that would have allowed the agency to regulate lab-developed tests as medical devices. Under the rule, the FDA would have phased in oversight of laboratory-developed tests ...
The U.S. FDA’s final rule for regulation of lab-developed tests was destined to be controversial at best and exceptionally susceptible to legal challenge according to more than one legal opinion. The ...
FDA’s Authority Over Lab-Developed Tests Overturned: What the Court’s Decision Means for Lab Testing
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