EmailMe Form - AABB-New Exhibitor Questionnaire

Name *

First Last

Company Name *

Address *

Street Address Address Line 2 City State / Province / Region Postal / Zip Code Country / Region

Title/Role *

Email *

Phone *

Web Site *

Products you will be exhibiting *

No product, apparatus, instrument, device, or drug that 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 that have been determined to be medical devices, as defined by the Federal Food, Drug, and Cosmetic Act, Section 201(h).

All devices that have not obtained FDA market clearance and are intended for use on humans or that are not commercially available in the US will be permitted for exhibit only when accompanied by the appropriate signs that indicate their status. The following are signs that should be displayed: (1) “This device is not for distribution in the United States”; (2) “Device is limited by federal law for investigational use”; (3) “Cleared for marketing when intended for only”; (4) “Pending FDA market clearance.” The 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 must be identified on the Exhibit Space Application or attached documents and must include FDA market clearance status, if applicable. This form will become part of the original application and contract.

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.