MedTech Dive May 30, 2024
The American Clinical Laboratory Association argues the agency does not have the authority to enforce the stricter standards on lab developed tests.
The American Clinical Laboratory Association (ACLA) sued the Food and Drug Administration on Wednesday, arguing the agency does not have the authority to regulate laboratory developed tests as medical devices.
The trade group wants the FDA’s final rule vacated, according to a lawsuit filed in the U.S. District Court for the Eastern District of Texas.
The FDA moved forward with the controversial rule in April, tightening its oversight of the widely used tests in an effort to make them safer and more accurate. The agency contends the risks associated with LDTs, a category of in vitro diagnostics designed...
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