Strategic Decision Making Case Studies

Strategic Decision Making Case Studies-15
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.

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.

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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.

Under MDR requirements, manufacturers of medical devices are required to report deaths and serious injuries caused by malfunctions of medical devices to FDA.

User facilities are required to report serious injuries associated with medical devices to their manufacturers and to report deaths to both the manufacturers and FDA (FDA 2009a).

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