WASHINGTON — U.S. Senator Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, today released a statement on the U.S. Food and Drug Administration’s (FDA) recent proposed rule amending FDA regulations to classify Laboratory Developed Tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act. This proposed rule would greatly increase FDA regulatory oversight and enforcement over the development, production and distribution of LDTs.
“The FDA does not have the authority to unilaterally expand its regulatory jurisdiction. We saw during the pandemic how too much government interference and red tape could do more to delay lifesaving care,” said Dr. Cassidy. “While past legislative efforts may have missed the mark, it is time for Congress to assert itself and clarify FDA’s authority in the regulation of diagnostic tests.”