| The challenges of clinical validation of emerging technologies: computer-assisted devices for surgery. | |
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MedLine Citation:
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PMID: 19182016 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Over the last decade, the use of computers and robotics in medicine has increased commensurate with emergent advances in technology. This article largely focuses on the challenges that the U.S. Food and Drug Administration faces when evaluating new technologies for entry into the market. How different categories of devices are categorized and what types of data have been used for regulatory approval or clearance are described. These are compared with expectations that the clinical community may have for these devices. A brief discussion of current regulatory thinking about these types of devices is also included. |
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Authors:
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Michel Janda; Barbara Buch |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: The Journal of bone and joint surgery. American volume Volume: 91 Suppl 1 ISSN: 1535-1386 ISO Abbreviation: J Bone Joint Surg Am Publication Date: 2009 Feb |
Date Detail:
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Created Date: 2009-02-02 Completed Date: 2009-03-17 Revised Date: 2010-10-25 |
Medline Journal Info:
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Nlm Unique ID: 0014030 Medline TA: J Bone Joint Surg Am Country: United States |
Other Details:
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Languages: eng Pagination: 17-21 Citation Subset: AIM; IM |
Affiliation:
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Division of General Restorative and Neurological Devices, Center for Devices and Radiologic Health, U.S. Food and Drug Administration, 9200 Corporate Boulevard, HFZ-410, Rockville, MD 20850, USA. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Device Approval Humans Orthopedic Procedures / instrumentation* Surgery, Computer-Assisted / instrumentation* Validation Studies as Topic |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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