EmailMe Form - AABB-New Exhibitor Questionnaire

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Products you will be exhibiting *

No product, apparatus, instrument, device, or drug which is the subject of litigation pending before the US Food & Drug Administration (FDA) may be exhibited. All Exhibitors for which FDA market clearance applies shall have documentation from the FDA on all products being displayed available at the booth. The documentation should state the model and regulatory class of those products determined to be medical devices, as defined by the Federal Food, Drug, and Cosmetic Act, Section 201(h).

Devices without FDA market clearance and are intended for use on humans or are not commercially available in the US will be permitted for exhibit only when accompanied by the appropriate signs indicating their FDA status. The following are signs that should be displayed: (1) “This device is not FDA approved for distribution in the United States”; (2) “This device is FDA approved for investigational use only in the United States”; (3) “This device is FDA cleared for marketing in the US as substantially equivalent to a similar, legally marketed device”; (4) “This device has not yet received FDA clearance for marketing in the US as substantially equivalent to a similar, legally marketed device.” Signs must be easily visible and placed on or near the device itself and on any graphics depicting the device.

All products to be exhibited at 2025 AABB Annual Meeting must be identified on the application/contract and must include FDA market clearance status. Applications received without insurance information, an authorized signature, FDA information, and/or the required deposit will not be accepted or processed until the conditions of acceptance are met. AABB reserves the right to reject any application in its sole discretion.

NOTE: Prior to receiving the FDA market clearance of a 510(k) for a device, a manufacturer is limited in what promotional activities may be undertaken with regard to the device. Prior to the clearance of a 510(k), a manufacturer may advertise or display the device, but the device may not be sold, given away, held, or offered for sale, nor may orders be solicited, even upon the qualification that orders cannot be filled until the FDA acts on the 510(k), unless the device is limited to research or investigational use.

The failure to file a 510(k) is a misbranding violation [21 USC 352(o)]. Please contact the FDA Office of Compliance regarding your responsibilities under the Federal Food, Drug, and Cosmetic Act at 301-594-4692.