USA – Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers

This guidance provides information for firms about how FDA evaluates firms’ medical product communications that fall within the scope of FDA’s regulatory authority (product
communications) and that present information not contained in the FDA-required labeling for the product but that may be consistent with the FDA-required labeling for the product.

For the purposes of this guidance and as further explained in section III, 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 (510(k)) requirements or exempt from premarket review, the term FDA-required labeling includes the labeling that provides adequate directions for use and other information required to appear on the label or in labeling…