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Government Regulation

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Submitted By caitlyn05
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1. Pre-marketing control- Entails regulating industrialized organizations, product quality, and advertising before product-launch to the market. In each case, compliance is required with the relevant legislation and regulations. In addition, pre-market approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. 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. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices. Therefore, these devices require a premarket approval.
(FDA U.S. Food and Drug Administration, 2013).

2. Post-marketing control- According to "FDA U.S. Food and Drug Administration" (2013), Post-market surveillance is an assortment of processes and activities the FDA uses to screen the safety and efficiency of medical devices once they are on the market. These actions are designed to produce information to rapidly identify below par performing devices and other safety glitches, precisely characterize real-world device performance, clinical outcomes, and facilitate the development of new devices, or new uses for existing devices.

3. Consumer Education- According to "Direct-To-Consumers Prescription Drug Advertising" (March 2010), The FDA identifies three types of DTC ads: 1) reminder ads that include no reference to the drug’s purpose, benefits, or risks, and that refer to the drug’s brand name only, 2) help-seeking ads that contain information about a disease or medical condition without mentioning the drug’s brand name, and 3) product-claim ads that include both the drug’s brand name and contraindications.6 Product-claim ads are the most common and controversial type of DTC advertising and are the ones regulated by the FDA. The FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) oversee DTC advertising, monitoring ads to make sure information is “truthful, balanced, and accurately communicated.” Drug companies may voluntarily submit draft versions of DTC advertising materials for advisory comments.1 However; the FDA does not mandate a premarket review of DTC advertising unless the drug was approved on an accelerated basis. Drug makers must submit final DTC ad materials to the DDMAC at the time of initial product dissemination.


FDA U.S. Food and Drug Administration. (2013). Retrieved from

In-Text Citation

Insert the paraphrased material ("FDA U.S. Food and Drug Administration", 2013).

The "FDA U.S. Food and Drug Administration" (2013) website Insert the paraphrased material.

According to "FDA U.S. Food and Drug Administration" (2013), "Insert the quotation” (para. 2).
Note: In a long online document

2. Direct-to-Consumer’s Prescription Drug Advertising. (March 2010). Retrieved from

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