This guidance provides information for firms about how FDA evaluates firms’ medical product communications, including promotional materials, that present information that is not contained in the FDA-required labeling for the product but that may be consistent with the FDA-required labeling for the product. As used in this guidance and further explained below, information that is consistent with the FDA-required labeling is limited to information about the approved or cleared uses of a product. The term FDA-required labeling as used in this guidance includes the labeling reviewed and approved by FDA as part of the medical product marketing application review process. For products not subject to premarket approval, but instead subject to premarket notification requirements or exempt from premarket review, the term FDA-required labeling also includes the labeling relied on to provide adequate directions for use and other information required to appear on the label or in labeling.

FDA has received a number of questions concerning this topic. As a result, FDA is providing guidance in a question and answer format, addressing frequently asked questions.

Posted on the FDA website on 17 January 2017