What are the applicable laws for advertising of medical devices?

In Delaware, the laws for advertising of medical devices are subject to a variety of federal and state regulations. Under the Federal Food, Drug, and Cosmetic Act (FDCA), both medical devices and their advertising must be proven as safe and effective before they can be sold in the USA. The U.S. Food and Drug Administration (FDA) is responsible for enforcing these laws through the Center for Devices and Radiological Health (CDRH). At the state level, the Delaware Division of Professional Regulation oversees medical device advertising. Advertising of medical devices must be truthful and not misleading. All advertising must contain information about the risks and benefits of the device. Advertisements must also include the name of the manufacturer and name of the medical device. In addition, medical device advertisements must contain a statement affirming that the product has been approved by the FDA. Ads which contain disclaimers or make general claims such as “treats all diseases”, “cures all ailments”, etc. are prohibited. Furthermore, any claims or representations made in an advertisement must be supported by evidence. Failure to comply with these regulations can result in fines, injunctions, and other legal penalties. Therefore, it is important for businesses in Delaware to familiarize themselves with these laws before advertising any medical devices.

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What are the applicable laws for advertising of medical devices?

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