Regulatory Agency Paper

1540 words 7 pages
Regulatory Agency Paper Annamarie Jenkins April 2, 2012 HCS/430

Federal Drug and Food Administration “The Federal Drug Administration is an agency within the Department of Health and
Human Services. The FDA organization consist of the Office of Commissioner and four directorates overseeing four core functions of the agency: Medical Products, and Tobacco,
Foods, Global Regulatory Operations, and Policy, and Operations” (FDA, 2011). The FDA
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The FDA makes sure that every aspect is looked at to make sure no law or regulation will be missed or broken. They will also make sure that those who work for them is safe as well in follow the employment regulations. Effects on Health Care The Federal Food and Drug Administration had many effects on health care. They help protect those, especially with medication and new innovations on procedures for certain types of surgeries. One procedure in particular would be heart value replacement in which a robot would do the procedure with the assist of the surgeon. “The FDA has approved the use of the De
Vinci and the Zeus robots in controlled clinical trials for heart procedures” (Gerhardus, 2003, p.
244). The controlled clinical trials are no longer for many hospitals are using these robots today for these heart procedures. The FDA has made sure that medications have been properly label both behind the counter and in front of the counter. This allows the providers and patients know exactly what the medication consists of and any warnings of side effects the medication may have. These are important to know if a patient may have allergies to a specific medication to prevent any type of a reaction. The FDA makes sure this information is available to ensure the safety of the patient. Example of Agency Carrying Out Duties The Federal Drug and Food Administration

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