77 Food and Drug Administration

77 Name: Course: Professor Name: (October 10, 2012) 77 The Food and Drug Administration (FDA) is a department of the united state health and human service. Its role is ensuring public health by ensuring safety in human and veterinary drugs .It also speeds up innovation that enhances medicine efficiency, this helps the public to get correct information about medicine and food to improve on their health. For FDA to approve a device, it has to consider some factors such as the clinical data, risks and benefits of the patient in using the device. Premarket approval is a scientific and regulatory review process FDA uses to check the effectiveness of class III medical devices. The Class III devices are those that help to sustain human life by preventing impairments and risk to human health. When evaluating the premarket approval, FDA relies on scientific evidence to confirm the safety and effectiveness. The FDA ensures transparency of the decision reached after premarket approval evaluation has been done. This is by providing a worksheet analysis in the summary of effectiveness and safety of the devic...