What are the applicable laws for advertising of medical devices?

In Kansas, medical device manufacturers and distributors must comply with both Federal and state laws and regulations when advertising medical devices. Under Federal law, the regulation of medical device advertising is largely the responsibility of the United States Food and Drug Administration (FDA). The FDA requires that all medical device advertising not be false or misleading, and must include specific information regarding the safety and efficacy of the device. Under Kansas state law, medical device manufacturers and distributors must provide proof of FDA approval prior to advertising their products. Additionally, the labeling and advertising of medical devices must accurately reflect the approved indications for use and relevant warnings, precautions, and contraindications. Kansas also requires that medical device advertising be conducted in accordance with established ethical standards. In order to comply with applicable laws, medical device manufacturers and distributors are encouraged to insure that all their advertising meets the criteria of the FDA and Kansas state laws. Additionally, they should seek legal advice if they have questions or need assistance in meeting the requirements for advertising medical devices.

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What are the applicable laws for advertising of medical devices?

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