Strategic Decision Making Case Studies

The FDA Center for Devices and Radiological Health regulates an estimated 220,000 devices, reviews around 3,500-4,000 new products each year, and monitors some 1,000 product recalls each year. Items as varied as tongue depressors, tubing, and pacemakers are under the purview of this FDA center. At ANU 1 EFTSL is 48 units (normally 8 x 6-unit courses).

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Strategic Decision Making Case Studies Scholarly Essay

In 2009, FDA reported that there were 160 Class I recalls, over 500 Class II recalls, and 172 Class III recalls (FDA 2010a). The ANU uses Turnitin to enhance student citation and referencing techniques, and to assess assignment submissions as a component of the University's approach to managing Academic Integrity.While the use of Turnitin is not mandatory, the ANU highly recommends Turnitin is used by both teaching staff and students.Public sector decision makers operate in an environment where evidence may be patchy or non-existent; there may be debate about the nature of the available evidence; there may be multiple potential decision criteria; and decisions may have a profound effect on the lives of individual citizens.Through an analysis of real life case studies, this course presents students with a series of decision-making dilemmas.Not all the recalled products were in clinical use, so the recalls may have prevented additional future exposures. Many recalls of implanted medical devices are based partly on postmarket surveillance data. A universal, one-size-fits-all system for medical-device reporting and postmarket surveillance has not yet reached the level of success that FDA would like. The existing FDA medical-device reporting systems—Manufacturer and User Facility Device Experience (MAUDE) and Medical Device Reporting (MDR)—contain a great deal of information that cannot be reliably analyzed, and the agency is studying new approaches to postmarket surveillance under the Sentinel Initiative. If you are a domestic graduate coursework or international student you will be required to pay tuition fees. Further information for domestic and international students about tuition and other fees can be found at Fees.If you are an undergraduate student and have been offered a Commonwealth supported place, your fees are set by the Australian Government for each course.


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