Exhibitors are expected to abide by all applicable FDA regulations. Exhibitors shall have available at their table a letter from the FDA that describes the allowable use status of the product.
Exhibitors are reminded of FDA restrictions on the promotion of investigational and pre-approval drugs and devices, and the prohibition on promoting approved drugs and devices for unapproved uses.
All products which are not FDA approved for a particular use in humans or which are not commercially available in the U.S. will be permitted to be exhibited only when accompanied by the appropriate signs that indicate their status.
The signs must be easily visible and placed near the product and on any graphics depicting the product. The following are signs that should be displayed:
- Device/product is not for distribution in the United States
- Device/product is limited by Federal Law for investigational use
- Cleared for marketing when intended for _______________ (type of use) only