Association for Diagnostics & Laboratory Medicine (formerly AACC) Statement on Proposed FDA Rule on Laboratory Developed Tests
Association for Diagnostics & Laboratory Medicine (ADLM)We at the Association for Diagnostics & Laboratory Medicine were disappointed to see the U.S. Food & Drug Administration’s (FDA’s) attempt to circumvent Congress with its new proposed rule to duplicate the regulation of laboratory developed tests by placing these tests under FDA authority, in addition to their current regulation under the Centers for Medicare and Medicaid Services.