Validation of Medical Software: Present Policy of the Food and Drug Administration

Position paper1 April 1987Validation of Medical Software: Present Policy of the Food and Drug AdministrationFRANK E. YOUNG, M. D. , Ph. D. FRANK E. YOUNG, M. D. , Ph. D. Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps: //doi. org/10. 7326/0003-4819-106-4-628 SectionsAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail ExcerptAs the introduction of information management into the realm of medical devices takes place, the computer revolution markedly affects the regulatory responsibility of the Food and Drug Administration (FDA). According to the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act passed on 28 May 1976 (Public Law 94-295), a device is defined as ". . . an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any part of accessory which is. . . intended for use in the diagnosis of disease or other conditions or in the cure,. . . This content is PDF only. To continue reading please click on the PDF icon. Author, Article, and Disclosure InformationAffiliations: Rockville, Maryland▸This is an excerpt of an address presented on 16 September 1986 at the Sesquicentennial Banquet of the National Library of Medicine. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited ByClinical Decision Support in the Era of Artificial IntelligenceOverview of Clinical Decision Support SystemsDiagnostic Decision Support SystemsEthical and Legal Issues in Decision SupportLegal and Regulatory Issues Related to the Use of Clinical Software in Health Care DeliveryA comparative review of patient safety initiatives for national health information technologyThe evolution of eProtocols that enable reproducible clinical research and care methodsEthical and Legal Issues in the Use of Health Information Technology to Improve Patient SafetyLegal and regulatory issues related to the use of clinical software in health care deliveryClinical Diagnostic Decision Support Systems—An OverviewEthical and Legal Issues in Decision SupportDesiderata for product labeling of medical expert systemsRecommendations for Responsible Monitoring and Regulation of Clinical Software SystemsA model for the assessment of medical workstations for health care supportComputer-assisted test interpretation: Considerations in patient careA Method to Describe Physician Decision Thresholds and Its Application in Examining the Diagnosis of Coronary Artery Disease Based on Exercise Treadmill TestingThe use of expert systems in the healthcare industryFast static timing analysis of real-time systemsComputer R/: More harm than good? Computer-assisted diagnosis of rheumatic disordersComputerized Diagnostic Aid in GastroenterologyModularity and Integration of Medical and Health Information SystemsInformation management for decision making by critical care physicians and nursesThe Teaching of Statistics in the Biological, Medical and Health Sciences: Some Comments and a Selected BibliographyComputers in medicine: Liability issues for physiciansUse of computers in emergency medicineAntihypertensive Therapy for the Elderly: An Expert System to Assist Therapeutic DecisionsQuality controlling interpretive reporting systems in clinical medicine? A changing responsibilityComputerized diagnosis: implications for clinical educationDiagnostic Decision Support SystemsEthical and Legal Issues in Decision Support 1 April 1987Volume 106, Issue 4Page: 628-629KeywordsComputersDrug policyDrugsFoodFood and Drug AdministrationLibraries Issue Published: 1 April 1987 Copyright© 1987 American College of PhysiciansPDF DownloadLoading. . .