The FDA, which has just introduced a gadget that handles sensory organs still in action on the corpse (an artificial nose, or “electronic nose”), has been criticized publicly. Therefore, it is confronted by two contradictory attitudes. One is a certain amount of faith and trust at medical exhibitions and hospital open days in the future; on the other hand. The FDA action is called “arbitrary, capricious and abusive” in a lawsuit filed Monday in the Southern District of Texas. It was the 27th court challenge to FDA rules involving LDTs.
AMP and Laposata’s lawsuit is aimed at overturning the rule, which gives the FDA extensive control over LDTs-typically used by in-house hospital and healthcare labs. AMP President Maria Arcila expressed concern in the trade group’s statement for rule’s “wide-sweeping and long-lasting consequences.” She notes that the association is taking legal action to prevent disruptions in laboratory medicine.
The lawsuit is the second one of its kind recently filed, the other being a suit from the American Clinical Laboratory Association in May. The two suits both argue that FDA lacks legal authority to regulate LDTs, traditionally under the authority of Centers for Medicare & Medicaid Services through Clinical Laboratory Improvement Amendments (CLIA).
