title: Validation and regulation of medical neural networks.
abstract: Using artificial neural networks (ANNs) in medical applications can be challenging because of the often-experimental nature of ANN construction and the "black box" label that is frequently attached to them. In the US, medical neural networks are regulated by the Food and Drug Administration. This article briefly discusses the documented FDA policy on neural networks and the various levels of formal acceptance that neural network development groups might pursue. To assist medical neural network developers in creating robust and verifiable software, this paper provides a development process model targeted specifically to ANNs for critical applications.
authors.affiliation: Booz Allen Hamilton, Inc., Colorado Springs, Colorado 80910, USA. rodvold_david@bah.com
authors.forename: D M
authors.initials: DM
authors.lastname: Rodvold
mesh_terms: D018795:Device Approval; D016571:Neural Networks, Computer; D012308:Risk Management; D014481:United States; D014486:United States Food and Drug Administration