Ensuring Consumer Safety: Toward Redefining the U.S. Food and Drug Administration

4116 Words Apr 29th, 2013 17 Pages
Kayla Shelton
Professor Lodge
UNIV 200
14 April 2011
Ensuring Consumer Safety:
Toward Redefining the U.S. Food and Drug Administration The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the regulation and supervision of foods, medical devices, and prescription and over-the-counter pharmaceutical drugs (medications). The FDA regulates and supervises medical devices and drugs throughout their development, manufacturing, process of approval, marketing, and post marketing stages. When a drug or medical device is granted approval by the FDA, it will shortly become marketed in the United States and
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The third and final phase of drug trials involves a large number of volunteers in well-controlled settings. A variety of ways can be used to test the drug; however, placebo is the standard comparator for the drug (Wing et al.). After the completion of clinical trials, the data from the trials is submitted among other safety and efficacy reports in the NDA process. When the FDA receives the completed NDA, they begin their review process, which they are legally allowed ten months to review the application and submit their decision of approval (FDA). The label content is decided next, then the drug can be granted approval by the FDA. A drug approved by the FDA is said to be “safe and effective when used as directed on the label” (Wing et al.). Unlike prescription drugs, the FDA has two different regulatory standards for reviewing medical devices: premarket approval (PMA) and 510(k) clearance. The FDA classifies medical devices, according to their risk, through which they can be identified. There are Class I , Class II, and Class III medical devices. The PMA process is the FDA process of reviewing Class III medical devices. According to the FDA, “Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury” (FDA). The PMA process is the most stringent type of

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