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FDA decided to rescind the LDT rule after declining to appeal a district court decision vacating it. The rule reflected FDA’s latest attempt to regulate LDTs under the same framework as IVDs, which FDA considers medical...more
In our May 2024 Healthcare Alert, we discussed a final rule published by the US Food and Drug Administration (FDA) amending its regulations to include in vitro diagnostic products (IVDs), even those manufactured in a...more
On March 31, a judge in the Eastern District of Texas vacated the US Food and Drug Administration’s (FDA) rule that sought to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and...more
A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more
The US Supreme Court has overruled the longstanding Chevron doctrine, an administrative law doctrine that required courts to defer to reasonable agency interpretations of ambiguous statutes. Loper Bright Enterprises v....more
Baker Donelson recently published Anticipating SCOTUS Ruling on Chevron Deference – What to Know and Five Ways to Prepare explaining the United States Supreme Court's upcoming ruling which is expected to impact the regulatory...more