What are the key legal risks in implantable device advertising?

Key legal risks include rendering legal disclaimers as images, inconsistencies in safety information, conflicting copy between banner and body text, softened adverse event language, and omission of side effects due to layout choices.

How can regulatory demands affect device advertising?

Regulatory demands require proper spacing between benefits and risks and adherence to FDA-approved advertising and labeling standards to ensure clear and compliant messaging.

What steps can be taken to manage risks in device advertising?

Steps include meticulous reviews of final files, using digital text extraction and manual verification, ensuring text-based disclaimers are compliant, adhering to FDA's spacing requirements, and preparing detailed risk review presentations.

What are some common misinterpretations in device advertisements?

Common misinterpretations include mistaking image-based disclaimers as creative design, conflicting safety information between primary text and ISI, inconsistent messaging between banner and body copy, and overlooking vital risk information due to layout omissions.

Why is precision in advertising important?

Precision in advertising is crucial not only for legal compliance but also as an ethical imperative to protect public health and uphold corporate integrity.

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