July 16, 2014

Laboratory Heads Urge OMB Not to Release FDA Guidance on the Regulation of Laboratory-Developed Tests

From: ARUP Laboratories

Letter Signed by Laboratory Directors of Nation’s Top Academic Medical Centers Warns That FDA Regulations Would Stifle Innovation and Compromise Patient Care

SALT LAKE CITY, July 16, 2014 (GLOBE NEWSWIRE) — Leading diagnostic innovators and laboratory directors from the nation’s most respected nonprofit, academic medical centers have issued a letter urging the Office of Management and Budget (OMB) not to release Food and Drug Administration (FDA) guidance for laboratory-developed tests (LDTs). Spearheaded by Edward R. Ashwood, MD, president and CEO of ARUP Laboratories and professor of pathology at the University of Utah School of Medicine, the letter states that FDA regulation would add yet another cumbersome layer to the already heavily regulated approval process for LDTs.

Many of the most technologically advanced academic clinical laboratories, including Harvard, Stanford, Yale, and Duke, criticize the FDA’s intent to issue guidance that would regulate diagnostic tests as medical devices under the Food, Drug and Cosmetic Act (FDCA).

Diagnostic testing is not a device but a medical service vital to the practice of medicine, and laboratories are not medical device manufacturers. Therefore, lab services are not under the jurisdiction of the FDA but rather the Centers for Medicare and Medicaid Services (CMS) and state medical licensing boards.

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