Displaying Investigational and Unapproved Medical Devices According to FDA Policy

October 1, 1997By: Jeffrey K. Shapiro Download PDF

Displaying investigational and unapproved devices at trade shows, in directed mailings, and on the Internet is important to the vitality of the medical device industry. For instance, to attract investment capital, manufacturers need to educate potential investors about the kinds of technology under development. In addition, new devices often require substantial capital outlays by purchasers, who can use advance knowledge of upcoming devices to plan for this type of purchase. Finally, product development can benefit from early feedback from potential users and the scientific community. Even the display of a device with a pending 510(k) submission-that is, a device that may be a new brand of an existing technology-allows the manufacturer to hit the ground running with sales after receiving clearance and thus to compete better with existing brands.