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.

Related FAQs

Are there any rules regarding the use of “opt-in” tactics in advertising?
Are there any special rules for advertising on social media sites?
What legal recourse do consumers have against deceptive advertising?
Are there any laws governing advertising of religious beliefs?
Are there any rules regarding the use of social media for advertising?
Are there any rules regarding the use of “bait and switch” advertising?
Are there any specific requirements for advertising of firearms?
Are there any restrictions or regulations on the use of research information or statistics in advertising?
Are there any restrictions on the use of “teaser” advertisements?
Are there any restrictions on the use of “scare” tactics in advertising?

What are the applicable laws for advertising of medical devices?

Related FAQs

Related Blog Posts