2014 Exhibitor Prospectus January 2014 volume 1 | страница 29

Rules and Regulations during the FIME annual meeting, which are directed toward FIME meeting registrants, must be confined to the exhibitor’s exhibit space. A. Device / Drug Products Equipment for demonstrations must not pose a safety hazard. If the equipment has energy beams that are hazardous, such energy beams must be made non-operative before installation. All products exhibited must be presented and marketed in strict compliance with all federal, state and local laws pertaining to the labeling and marketing of medical device and/or drugs. Device / drugs awaiting FDA approval (i.e., those qualifying for an Investigational Device Exemption), including but not limited to PMA and 501 (k) devices, must be identified to FIME as such at the time of application for exhibit space. Documentation of compliance with all applicable FDA guidelines relating to the marketing and promoti