title: FDA regulation of computerized cytology devices.
abstract: When talking about computerized cytology devices, a "different" aspect of quality assurance must be addressed. Any medical device intended for in vitro diagnostic use in the United States must be cleared or approved by the Food and Drug Administration (FDA): the May 28, 1976, Medical Device Amendments to the Federal Food, Drug and Cosmetic Act granted authority to the FDA to regulate medical devices. The FDA regulatory process as it relates to computerized cytology devices is discussed. This includes an explanation of the differences between the two types of documents used to clear a medical device: (1) premarket notification [510(k)] and (2) premarket approval (PMA) application. Devices intended for "research use only" are also discussed. A computerized cytology device of current interest, the "automated Pap smear reader," is used as an example to further discuss performance and software considerations.
authors.affiliation: Food and Drug Administration Center for Devices and Radiological Health, Rockville, Maryland.
authors.forename: L J
authors.initials: LJ
authors.lastname: Brindza
mesh_terms: D003201:Computers / Q000592:standards*; D003581:Cytodiagnosis / Q000295:instrumentation* / Q000592:standards; D012984:Software / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration