ACLA Opposes Unilateral FDA Action to Regulate Laboratory Developed Tests Under Medical Device Authority

September 29, 2023 

Washington, D.C. – The American Clinical Laboratory Association (ACLA) today issued the following statement after the U.S. Food and Drug Administration (FDA) released a proposed rule that would seek to regulate Laboratory Developed Tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act. ACLA does not believe that FDA’s actions are in the best interest of patients or our nation’s health care system. Because the proposed rule exceeds FDA’s existing authority, ACLA plans to submit comments urging FDA to withdraw the proposed rule and resume work with Congress, the laboratory community, patient groups, and other stakeholders toward a legislative solution that provides a framework that is appropriate for the unique attributes of LDTs.Continue reading

FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed Tests

For Immediate Release:
September 29, 2023

Today, the U.S. Food and Drug Administration announced a proposed rule regarding laboratory developed tests, or LDTs, which play an important role in healthcare. The rule is aimed at helping to ensure the safety and effectiveness of these tests, which are used in a growing number of health care decisions and for which concerns have been raised for many years.Continue reading

Newsweek Ranks Barrow No. 13 Globally, No. 10 Nationally for Neurosurgery

PHOENIX (Sept. 26, 2023) – Newsweek has again named Barrow Neurological Institute one of the World’s Best Specialized Hospitals for Neurosurgery.

In its third year of ranking hospitals in neurosurgery, the media company continues to recognize Barrow as No. 1 in the Southwest and No. 10 in the nation. The Institute climbed two spots globally, sitting at No. 13 for 2024. The list includes 125 hospitals total.Continue reading