The Association for Molecular Pathology has asked a Senate committee to consider its alternative to FDA’s proposed laboratory developed test (LDT) framework, giving the Centers for Medicare and Medicaid Services regulatory jurisdiction over the tests under a beefed-up Clinical Laboratory Improvements Amendments law.
The pathologists group, one of several that expressed disappointment with FDA’s LDT framework early on Also see "Lab Groups’ LDT Comments Will Highlight Barriers To Test Accessibility" - Pink...