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Accession Number
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PB2013-101271
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Title
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Scientific Disagreements Regarding Medical Device Regulatory Decisions.
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Publication Date
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Jun 2012
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Media Count
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30p
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Personal Author
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D. R. Levinson
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Abstract
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The Food and Drug Administration (FDA) plays a critical role in ensuring the safety and effectiveness of medical devices and other products. At the Center for Devices and Radiological Health (CDRH), a series of scientific disagreements received media attention between 2008 and 2010. In these instances, CDRH reviewers and their managers disagreed over whether medical devices under review met applicable review standards. In October 2009, CDRH issued new policies and procedures for resolving internal scientific disagreements related to regulatory decisions.
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Keywords
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Center for Devices and Radiological Health (CDRH)
Decision making
Government policies
Medical devices
Procedures
Product safety
Regulations
Reviews
Standards
US FDA
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Source Agency
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Department of Health and Human Services, Washington, DC
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NTIS Subject Category
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57E - Clinical Medicine
95C - Biomedical Instrumentation & Bioengineering
44H - Health Care Technology
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Corporate Author
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Department of Health and Human Services, Washington, DC. Office of the Inspector General.
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Document Type
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Technical report
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Title Note
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N/A
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NTIS Issue Number
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1303
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Contract Number
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N/A
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