By Bowling Green Today |
Dec 5, 2023
In a recent letter to Dr. Robert Califf, Commissioner of Food and Drugs at the U.S. Food and Drug Administration (FDA), U.S. Senator Rand Paul expressed his concerns about the FDA's proposed rule on Laboratory Developed Tests (LDTs). The proposed rule would impose the FDA's medical device regulatory framework on health care providers developing and performing LDTs, which Dr. Paul believes exceeds the FDA's statutory authority and conflicts with the Clinical Laboratory Improvement Amendments of 1988 (CLIA).Dr. Paul, in his letter, cited a white paper co-authored by legal...