FDA to Consider All Ad Content When Reviewing Risk Information

Devicemakers should focus on the overall impression their advertising conveys to healthcare professionals and consumers to determine whether the risk information in each promotional piece complies with the law and FDA regulations, according to a draft guidance. Omitting or minimizing risk information is the most frequently cited violation in advertising and promotion warning letters or untitled letters to sponsors, the guidance says. The draft follows congressional requests for more FDA regulation of device advertising.
Devices & Diagnostics Letter