Open AccessJournal Article
FDA regulation of computerized cytology devices.
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TL;DR: A computerized cytology device of current interest, the "automated Pap smear reader," is used as an example to further discuss performance and software considerations.
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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.
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Citations
Considerations on the quality of medical software and information services
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TL;DR: The needs and possibilities to assess the quality of medical decision support software and information services are discussed and informatics systems used by any health professional, and to computerised systems used to schedule care or to organise record systems are discussed.
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Classification of Cells in Cervical Smears
Mathilde E. Boon,L. P. Kok +1 more
- 01 Jan 1995
TL;DR: An increased effort to realize computer-assisted screening is generated in response to the American shortage of cytotechnologists after the Wall Street Journal in 1987 carried a major article questioning the accuracy of cervical screening in the USA.
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Validation of the laboratory information system.
TL;DR: System validation demonstrates to all concerned, inside and outside the laboratory, that the laboratory information system manages information well, with the expected accuracy and reliability, file integrity, auditability, and management control.
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State of the Art Symposium: prescreening and rescreening.
TL;DR: The effectiveness of prescreening and rescreening cervical cytology preparations—whether used as quality assurance measures or in the attempt to improve sensitivity—has engendered broad discussion within the cytology community.
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3 of the Laboratory Information System
Daniel F. Cowan,R. Zane Gray,Beverly C. Campbell +2 more
- 01 Jan 1998
TL;DR: The intention here is to discuss LIS validation as it applies in the laboratory in general, to define the issues related to validation, and to suggest an approach to dealing with them.