What are the applicable laws for advertising of medical devices?
In California, all advertisements of medical devices must adhere to the applicable laws and regulations set forth by the Federal Drug Administration (FDA) and the California Department of Public Health (CDPH). Medical devices are classified by the FDA as products that are used to diagnose, treat, or prevent diseases or other conditions. As such, advertising of these products must abide by the labeling and advertising regulations set forth by the FDA. This includes, but is not limited to, providing the product’s indications, contraindications, warnings, and benefits; verifying the accuracy of the advertisement; and disclosing any risks associated with the medical device use. The CDPH requires advertisement of medical devices to adhere to the California False Advertising Law. This mandates that all advertisers must provide enough information for customers to make an informed decision and prevents false and misleading claims in medical device advertisements. Overall, any medical device advertisement in California must abide by the FDA and CDPH regulations to maintain compliance with advertising law. The FDA and CDPH have the authority to take legal action against any advertisement that is not in line with the applicable regulations. This is why it is essential for medical device advertisers to understand the applicable laws and regulations to ensure they are not in violation of the law.
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