WASHINGTON, D.C. – Yesterday, U.S. Senator Rand Paul (R-KY) sent a letter to Dr. Robert Califf, Commissioner of Food and Drugs at the U.S. Food and Drug Administration (FDA) about the FDA’s recent proposed rule on Laboratory Developed Tests (LDTs). The proposed rule would inappropriately impose the FDA’s medical device regulatory framework on health care providers developing and performing LDTs as part of their professional practice. It would also cause unnecessary disruptions to patient care.
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