title: How will the FDA impact the laboratory developed test?
authors: ASCLS Government Affairs Committee, ASCLS, 6701 Democracy Boulevard, Suite 300, Bethesda MD 20817, USA.
authors: Judy
authors: J
authors: Davis
authors: John
authors: J
authors: Wentz
mesh_terms: D019411:Clinical Laboratory Techniques / Q000379:methods* / Q000592:standards*; D018795:Device Approval; D005820:Genetic Testing / Q000331:legislation & jurisprudence / Q000379:methods* / Q000592:standards*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*