FDA Statement

Some drugs or medical devices demonstrated at the Annual Meeting have not been cleared by the FDA or have been cleared by the FDA for specific purposes only. The FDA has stated that it is the responsibility of the physician to determine the FDA clearance status of each drug or medical devices he or she wishes to use in clinical practice.

Academy policy provides that “off label” uses of a drug or medical device may be described in the Academy’s CME activities so long as the “off label” use of the drug or medical device is also specifically disclosed (i.e. it must be disclosed that the FDA has not cleared the drug or device for the described purpose). Any drug or medical device is being used “off label” if the described use is not set forth on the products approval label.


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