title: FDA's framework for regulatory oversight of LDTs.
authors.affiliation: 1 University of Maryland , College Park, Maryland.
authors.forename: Bhagyashri
authors.initials: B
authors.lastname: Pathak
authors.forename: Sharon F
authors.initials: SF
authors.lastname: Terry
mesh_terms: D019411:Clinical Laboratory Techniques / Q000379:methods* / Q000592:standards*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration