Issues associated with off label use of medical devices

Off label use as applied to medical devices is the application of the device for a purpose that is not included as an indication in the FDA and EC approved device labeling. Such applications are also called unapproved or new uses. Beyond a use not being indicated, some off label uses may be expressly contraindicated as well as explicitly warned against. One example here is the currently controversial topic of the reuse of devices labeled single use only, although off label use is a far more widespread issue than reuse. The justification for off label use can range from reasoned and studied applications beyond those for which the manufacturer has sought clearance or approval, to misapplication based on faulty analysis or ignorance. This paper will review the critical need to incorporate a risk assessment process for potential off label use.