Engineering Open-Source Medical Devices by Unknown

Author:Unknown
Language: eng
Format: epub
ISBN: 9783030793630
Publisher: Springer International Publishing

The institution responsible for regulating MDs in the United States is the Food and Drug Administration (FDA). The FDA uses a risk-based classification system, which classifies medical devices into the following three categories: Class I, Class II and Class III. Class I devices are associated with the lowest risk, while Class III devices are associated with the highest risk. Each device is assigned to a panel (cardiovascular, anaesthesiology, etc.). The panel determines the class and special controls and exemptions applicable to the device. Class I devices are defined as non-life sustaining and present minimal harm potential to user. These devices are typically simple in design, manufacture and have a history of safe use. Class II medical devices are devices where general controls are not sufficient to assure safety and effectiveness and existing methods/ standards/guidance documents are available to provide assurances of safety and effectiveness. Class III devices usually support or sustain human life. For Class III medical devices, sufficient information is not available to assure safety and effectiveness through the application of general controls and special controls. Typically, a pre-market approval submission to the FDA is required to allow marketing of a Class III medical device.

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