FDA Can't Regulate Lab Tests As Devices, Group Says

Law360, New York (June 6, 2013, 6:16 PM EDT) -- The American Clinical Laboratory Association on Tuesday challenged the U.S. Food and Drug Administration’s authority to regulate so-called laboratory developed tests, responding to the agency’s statements that it plans to regulate the tests as devices under the Food, Drug and Cosmetic Act.

The ACLA, a nonprofit representing the clinical laboratory services industry, filed the petition two days after FDA Commissioner Margaret Hamburg said at a medical conference that it's problematic that LDTs, which are lab-developed in vitro diagnostic tests that can detect diseases, conditions or infections,...
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