title: FDA: Gene tests need premarket approval.
authors.forename: Bridget M
authors.initials: BM
authors.lastname: Kuehn
mesh_terms: D003132:Commerce; D003256:Community Participation; D018795:Device Approval; D005820:Genetic Testing / Q000331:legislation & jurisprudence / Q000592:standards*; D008389:Marketing of Health Services; D014481:United States; D014486:United States Food and Drug Administration