The US Food and Drug Administration (FDA) has issued proposed advertising guidelines for drug and medical device manufacturers. This draft guidance describes factors FDA considers when evaluating promotional materials for drugs and medical devices with regard to the disclosure of risk/benefit information. These proposed guidelines will have implications for diagnostic firms looking for premarket approval for genetic tests that the FDA deems high-risk medical devices.
The draft guidance discusses factors that are relevant to the 22 disclosure of risk information and provides numerous examples to illustrate FDA’s thinking on these 23 factors. This guidance responds to stakeholder requests for specific guidance on how FDA evaluates 24 prescription drug and medical device promotional pieces to determine whether they adequately present 25 risk information. The recommendations contained in this draft guidance apply to promotional materials 26 directed to both consumers and healthcare professionals.