The FDA Office of Device Evaluation (ODE) Vendor Day Program provides FDA scientific and medical reviewers an opportunity to become more familiar with products they review and to interact with industry representatives (typically 3 to 4 individuals: engineers, clinical staff and regulatory staff) in an informal setting. Participating industries display their products and other items such as videotapes and product simulators that allow FDA staff to better understand the product. This interaction improves reviewers’ understanding of product design, operation, and application of devices. The Vendor Day is educational, not promotional, and therefore device displays and product demonstrations highlight the scientific basis and clinical use of the product. “Hands on” opportunities allowing FDA staff to hold, use, or operate devices are helpful in increasing the FDA’s understanding of devices and should be provided whenever possible. Vendor Day is often the first time reviewers and other staff see the actual devices they review.
Aside from the educational benefits afforded to FDA staff, the Vendor Day Program also engenders improved communications between industry and FDA and provides both groups with a better understanding of the health issues involved with medical device technology.
Vendor Days are usually held from 11:00 to 2:00 in the Atrium of Building 66 at FDA’s White Oak facility. Announcement of vendor day is made throughout the FDA White Oak campus so the event attracts a wide range of FDA employees. Display items may be carried to the site on the day of the event or shipped in advance. FDA hosts 10 to 12 companies at each Vendor Day.
In order to ensure consideration by FDA for this Vendor Day, please email Elliott Warren at firstname.lastname@example.org and list the name, title and contact information for the individuals from your company that would like to participate by COB, Friday, May 1.