Earlier this month, the Food and Drug Administration (“FDA” or “the Agency”) issued a highly anticipated proposed rule outlining the regulatory framework and implementation plan for Laboratory Developed Tests (“LDTs”).[1] The LDT regulatory status is long and meandering—and summarized below—but, critically for FDA, LDTs have historically been a medical product category for which FDA has exercised enforcement discretion.
Unsurprisingly, the proposed rule has already received significant pushback, with industry participants claiming that FDA’s interpretation of the Food, Drug, and Cosmetics Act (“FDCA”) is overly expansive and that the Agency does not, in fact, have the authority to regulate lab-developed diagnostic products.
