Association for Diagnostics & Laboratory Medicine (formerly AACC) Response to CMS Statement on FDA LDTs Proposed Rule
Association for Diagnostic and Laboratory Medicine (ADLM (formerly AACC))“We at the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) were surprised to see a statement from Drs. Jeff Shuren and Dora Hughes from the Centers for Medicare & Medicaid Services (CMS) in support of the U.S. Food & Drug Administration’s (FDA’s) proposed rule to duplicate the regulation of laboratory developed tests by placing these tests under FDA authority, in addition to their current regulation under CMS.