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dc.contributor.authorThompson, Zachery Matthew
dc.date.accessioned2014-03-04T21:04:34Z
dc.date.available2014-03-04T21:04:34Z
dc.date.issued2013-05
dc.identifier.otherthompson_zachery_m_201305_ms
dc.identifier.urihttp://purl.galileo.usg.edu/uga_etd/thompson_zachery_m_201305_ms
dc.identifier.urihttp://hdl.handle.net/10724/28934
dc.description.abstractClear differences in the way FDA regulates human and veterinary medical devices were noticed by the researcher during tenure as a Quality Assurance professional in the animal health industry. This prompted research which examined the differences in regulation of human and veterinary medical device pre-market clearance, manufacturing control, and post-market surveillance through the review of data describing the development of federal laws, authorized agencies, and regulatory methodologies applied to device regulation. The research methodology included the evaluation of identifiable gaps in regulation and qualitatively assessed risk to veterinary medical device safety and effectiveness relative to identifiable gaps. Multiple gaps were identified and the magnitude of risk to veterinary medical device safety and effectiveness, and impact to human safety, was established.
dc.languageeng
dc.publisheruga
dc.rightspublic
dc.subjectHuman
dc.subjectVeterinary
dc.subjectDrug
dc.subjectDevice
dc.subjectBiologic
dc.subjectApproval
dc.subjectManufacturing
dc.subjectManufacturing Control
dc.subjectPost-market Surveillance
dc.subjectRegulation
dc.subjectFDA
dc.subjectUSDA
dc.subjectRisk-based
dc.titleAnalysis of variability in regulatory requirements for product approval, manufacturing, and post-market surveillance of human and veterinary medical devices in the United States
dc.typeThesis
dc.description.degreeMS
dc.description.departmentBioPharma Regulatory Affairs
dc.description.majorPharmacy
dc.description.advisorDavid Mullis
dc.description.committeeDavid Mullis
dc.description.committeeGary Dykstra
dc.description.committeePaul Brooks


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