February 20, 2023

Marketing for Off-Label Use

In a nutshell, ALL of a manufacturer’s advertising/promotional statements must be within the boundaries established by the FDA-cleared/approved intended use and indications. Consequently, if a manufacturer makes claims that the subject device has been tested for, or can be used for, features not directly within the boundaries established by the FDA-cleared/approved intended use and indications, then that generally misbrands the device by way of marketing for uncleared/unapproved indications.

The FDA doesn’t generally prohibit clinicians from using their clinical judgment/expertise in the use of medical devices outside of the manufacturer’s labeled intended use / indications.  Clinicians are allowed to decide whether such “off-label” use is in their patient’s best interest.