title: Editorial Perspective: How should child psychologists and psychiatrists interpret FDA device approval? Caveat emptor.
abstract: Recently several new tests have received US Federal Drug Administration (FDA) marketing approval as aids in the diagnostic process for attention deficit hyperactivity disorder (ADHD), including the Neuropsychiatric electroencephalogram (EEG)-Based ADHD Assessment Aid (NEBA) Health test. The NEBA test relies upon an EEG-based measure, called the theta to beta ratio (TBR). Although this measure has yielded large differences between ADHD and non-ADHD groups in studies prior to 2009, recent studies and a meta-analysis could not replicate these findings. In this article, we have used the NEBA device as an exemplar for a discussion that distinguishes between FDA de novo marketing approval for a device and any claims that that device is empirically supported, scientifically validated with replicated findings. It is understood that the aims of each differ; however, for many, including the lay public as well as some mental health professionals, these terms may be confused and treated as though they are synonymous. With regard to the TBR measure, there is no reliable association or replication for its clinical usage in the ADHD diagnostic process. The recommendation for potential consumers of the NEBA Health test (as well as perhaps for other existing FDA-approved diagnostic tests) is caveat emptor (let the buyer beware!).
authors.affiliation: Research Institute Brainclinics, Nijmegen, The Netherlands.|Department of Experimental Psychology, Utrecht University, Utrecht, The Netherlands.|neuroCare Group, Munich, Germany.
authors.forename: Martijn
authors.initials: M
authors.lastname: Arns
authors.affiliation: Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience, University of California, Los Angeles, CA, USA.
authors.forename: Sandra K
authors.initials: SK
authors.lastname: Loo
authors.affiliation: Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience, University of California, Los Angeles, CA, USA.
authors.forename: M Barry
authors.initials: MB
authors.lastname: Sterman
authors.affiliation: Department of Child & Adolescent Mental Health, University Hospital of Erlangen, Erlangen, Germany.|Kbo-Heckscher-Klinikum, München, Germany.
authors.forename: Hartmut
authors.initials: H
authors.lastname: Heinrich
authors.affiliation: MRC Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, London, UK.
authors.forename: Jonna
authors.initials: J
authors.lastname: Kuntsi
authors.affiliation: MRC Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, London, UK.
authors.forename: Philip
authors.initials: P
authors.lastname: Asherson
authors.affiliation: Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Mannheim, Germany.
authors.forename: Tobias
authors.initials: T
authors.lastname: Banaschewski
authors.affiliation: Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Mannheim, Germany.|Department of Child and Adolescent Psychiatry, University of Zurich, Zurich, Switzerland.|Center for Integrative Human Physiology, University of Zurich, Zurich, Switzerland.|Neuroscience Center Zurich, University of Zurich and ETH Zurich, Zurich, Switzerland.
authors.forename: Daniel
authors.initials: D
authors.lastname: Brandeis
mesh_terms: D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis*; D002665:Child Psychiatry / Q000592:standards; D018795:Device Approval / Q000592:standards*; D004569:Electroencephalography / Q000295:instrumentation*; D006801:Humans; D002666:Psychology, Child / Q000592:standards
keywords: Attention deficit hyperactivity disorder; Electroencephalogram-Based Attention Deficit Hyperactivity Disorder Assessment Aid; Federal Drug Administration; diagnostic test; electroencephalogram; theta-to-beta ratio