Audio Visual Components in Exhibits
Exhibitors in compliance with the following noise abatement policy, may use sound amplification when conducting live presentations. Alternatively, wireless headsets may be more appropriate based on the booth size.
The exhibitor noise abatement policy is as follows:
- All booth elements must remain within the officially contracted booth space. This includes all truss work, lighting, audio equipment, speakers, etc.
- Live presentations in an open display should use a sound chamber or acoustically contained area to keep the sound level from intruding on any adjacent exhibits.
- Speakers of any kind must be directed toward the interior of the demonstrator's booth space. Speakers may not face aisles or neighboring exhibits.
The Academy reserves the right, in its sole discretion, to determine when sound levels from audiovisual equipment constitute interference with others or becomes unacceptable. Sound complaints will immediately be addressed and if not resolved, show management reserves the right to shut down power immediately until the issue is resolved.
Exhibitors are responsible for obtaining appropriate licenses for any copyrighted music used in their exhibit.
Exhibits must be staffed each day during exhibit hours until the close of the show at 1 p.m. on Tuesday, Oct. 30. Company representatives are expected to dress and conduct themselves in a professional manner, consistent with a medical meeting, and be wearing their personal Academy-issued exhibitor meeting badge.
Exhibitors are responsible for securing approval from the Director of Exhibitions for product demonstrations, promotions, activities, or presentations that may be questionable or lack credible scientific support. All product demonstrations, promotions, activities or presentations that are not evidence based or medically proven must include appropriate and prominent disclaimers. The Academy reserves the right to cancel any demonstration, promotion, activity or presentation that does not have the appropriate disclaimers or for which the Academy has not been notified.
Live human-subject demonstrations of techniques on the exhibit hall floor are prohibited.
All product and service demonstrations, interviews, instructional activities, and distribution of promotional literature within McCormick Place are to be confined to the limits of the assigned exhibit space. Any person canvassing outside his or her company’s exhibit booth will be asked to vacate the building, and the exhibiting company will be penalized priority points.
Display of Drugs and Devices Not Approved by the Federal Food and Drug Administration (FDA)
Any investigational product that is graphically depicted within the exhibit is subject to the following rules:
- Contain only objective statements about the product
- Contain no claims of safety, effectiveness, or reliability
- Contain no claims about how the product compares with marketed products
- Must be accompanied by directions for becoming an investigator and a list of investigator responsibilities
- Prominently display the statement “Caution—Investigational Device—Limited to Investigational Use” on the product in a type size that is easy to read
Exhibitors agree not to sell, promote, or distribute in any fashion any non-approved product, in whole or in part, during or in connection with the Academy’s meeting to U.S. attendees. Exhibitors may, however, conduct sales activities for, and market and promote, non-approved products, solely to attendees who are non-U.S. doctors, exclusively for sales outside the United States, provided that such activities are in compliance with the relevant laws of any such non-U.S. jurisdiction.
In accordance with U.S. law, exhibitors may not sell and deliver Non-FDA approved products to U.S. physicians at the meeting. Exhibitors may sell and deliver Non-FDA approved products to non-U.S. physicians as long as they adhere to all applicable U.S. laws and regulations.
You can find further information and guidance on the subject at www.fda.gov.
Penalties for noncompliance to the FDA rules and regulations include:
- The Academy, in its sole discretion, will immediately shut down the exhibitor’s booth for the remainder of the meeting.
- The exhibitor will not be entitled to a refund.
- The exhibitor may face legal action from the U.S. government for failing to comply with the appropriate rules and regulations.
- The exhibitor may not be invited to participate in future meetings.
Easily visible signage stating “This device is not cleared by the FDA for distribution in the United States” or “This device is limited by federal law to investigational use only” must be placed near the device or drug and on any graphic depicting the device or drug.
Exhibitors with non-FDA-approved products must complete the online General Liability Agreement by Friday, Aug. 24, indemnifying the Academy for losses arising out of the exhibition of investigational products or the violation of this agreement.
Lasers and Other Hazardous Light Sources
Exhibitors planning to demonstrate or display laser equipment and other hazardous light sources must indicate this intention on the Exhibit Space Application. Hazardous light sources include ultra violet lights designed to irradiate ocular tissues. Exhibitors planning to display (inoperative) or demonstrate (operative) lasers must complete the online Laser Safety Checklist, found in the Exhibitor Portal by Friday, Aug. 24.
- Laser safety information and guidelines for displaying or demonstrating laser will be included in the confirmation notice exhibitors receive once the Laser Safety Checklist is submitted.
- The company-appointed person responsible for all exhibited lasers (displayed or demonstrated) must be present when the LLSWG representatives inspect these lasers or their company will lose priority points.
- All lasers must pass inspection for mechanical stability, beam termination, enclosure reflections and beam access, or proper labeling.
- At the time of the inspection, all lasers that are being inspected for demonstration approval, must be fully operational as they would be during the exhibition hours.
The Academy’s Laser and Light Safety Working Group (LLSWG) will conduct an inspection of all lasers at the Retina Subspecialty Day exhibit program on Thursday, Oct. 25 and in the AAO 2018 exhibition on Friday, Oct. 26.
The inspections will begin at 5 p.m. and should conclude within two hours. The Academy will not allow operation of a health care laser system that has not been approved by a recognized regulatory agency unless it is accompanied by a detailed safety analysis by a laser safety professional. If a non-FDA approved health care laser system has a CE mark, it will be inspected by the LLSWG who will determine its suitability for operation during the meeting. The exhibiting company must have available, at the exhibit site, an operator’s manual containing safe operating instructions for these lasers.
Any laser system without a regulatory approval must be accompanied by a laser safety professional’s detailed safety review that will be made available to the LLSWG during the inspection. The review of this document will determine whether that laser may be operated during the meeting. This requirement includes Class I laser systems designed for diagnostic purposes.
- Exhibitors demonstrating or displaying lasers must comply with all provisions of ANSI Z136.1.
- Any laser employed as a laser light show must have a variance from FDA/CDRH.
- Compressed gas or compressed liquid cylinders used in the booth must be securely anchored to prevent toppling. Only a one-day, secured supply will be allowed in the display area.
- Companies operating lasers with non-FDA approved soft-ware must notify the Academy and label the instrument following the non-FDA guidelines found in “Display of Drugs and Devices Not Approved by the Federal Food and Drug Administration, (FDA),” earlier in this section.
- Any tissues used in demonstrations must be disposed of through the official wastes disposal contractor. (See “Wet Labs,” which follows in this section.)
The purpose of the exhibits is to further the education of meeting attendees through product and service displays and demonstrations. Consistent with this professional interest, order-taking and sale of exhibited products will be permitted, provided the transactions are conducted in an appropriately professional and businesslike manner.
If an exhibitor sells a product on the exhibit floor that cannot be carried out of the exhibit hall by hand, arrangements must be made to have the product shipped to the customer. Attendees will not be allowed on the exhibit floor after the exhibit hall closes on Tuesday, Oct. 30, at 1 p.m.
It is the responsibility of each exhibitor to secure any licenses or permits that might be required and collect and remit all city and state sales taxes.
The Academy reserves the right to restrict sales activities that it deems inappropriate or unprofessional.
Complete details and contact information for remitting taxes will be included in the Exhibitor Service Manual.
The Academy prohibits smoking in all meeting and exhibit areas. Your cooperation is appreciated.
Laser or instrument demonstration on tissue, either human or bovine, constitutes a wet lab; the same type of demonstration on fruits or vegetables is not considered a wet lab.
An exhibitor planning to conduct a wet lab on the exhibit floor must indicate this on the Exhibit Space Application and complete the online Wet Lab Request by Friday, Aug. 24. Exhibitors may only allow physicians to participate in the wet lab.
An exhibitor conducting a wet lab is required to use the official infectious waste disposal contractor and will be charged for medical waste disposal according to the number of wet lab stations in the booth.
- One to four wet lab stations: $200
- Five or more wet lab stations: $300
A floor manager will contact the individual charged with managing the wet lab onsite to provide complete instructions for obtaining supplies (red bags, boxes and sharp containers) and the drop-off locations for medical waste. Any company that fails to follow these directions are penalized the priority points they were to accrue for the meeting and may be prohibited from operating a wet lab at future Academy meetings.