Day 1 Schedule: Lecture 1:FDA authority and regulatory programTypes of Software are devicesRegulatory strategyRisk classificationFunction and outcomeMedical Device Data Systems (MDDS)Office of the National Coordinator (ONC) for Health Information ProtectionSoftware regulatory applicationsFDA GuidancePremarket submissionsParadigms: aeronauticsQuality System Regulation (QSR)Design verification and validationVoluntary standardsCorrective and Prevent Action PlansVoluntary standardsRecalls:Service / maintenance / recall.Implementation strategyCorrections and Removals reportingUpdates: FDA vs. non-FDAPredictive analyticsLecture 2:InteroperabilityCompatibility by designHardwareSoftwareLabelingPrecautionsInstructions for useUse of Voluntary StandardsProprietary informationFailure management / follow upUser's vs. manufacturer's legal responsibilitySystem configurationCustomizationEnvironment of useProfessionalHome useDay 2 Schedule: Lecture 1:CybersecurityDevice vulnerabilities: malfunction and failurePre-emption designLatent malware/virusPost-event managementCorrective action for softwareDisclosure to usersNational Institute of Science and Technology ReportLecture 2:Medical Mobile Applications (mobile apps)Mobile apps defined as a deviceFDA regulatory strategyFDA guidanceNational Institute of Science and Technology Report and CollaborationUpdates (FDA vs. non-FDA updates)Criteria for corrective and preventive action deemed recallsReports of Corrections and RemovalsReports of adverse eventsProfessional vs. lay use / home useLabeling: instructions for use and precautionsEnvironment of useFDA regulation of accessoriesFederal Communications Commission (FCC) regulation