title: The metrics of change: the impact of the FDA's pending LDT regulation.
authors.forename: Tadd S
authors.initials: TS
authors.lastname: Lazarus
authors.forename: Lena
authors.initials: L
authors.lastname: Chaihorsky
mesh_terms: D019411:Clinical Laboratory Techniques; D018795:Device Approval; D006801:Humans; D025202:Molecular Diagnostic Techniques; D014481:United States; D014486:United States Food and Drug Administration