In a letter to the FDA from December 2023, CAP President Donald S. Karcher, MD, FCAP, asked that some categories of LDTs continue under the FDA’s enforcement discretion policies. "Although there are currently many thousands of LDTs used in clinical care, most clinical laboratory tests performed today are low or moderate-risk and rely on packaged test systems produced by independent manufacturers and sold to laboratories," Dr. Karcher wrote.
For the full article click here: Precision medicine at tipping point with looming FDA LDT oversight