Executive Summary

CDRH personal conferencing: FDA's device center seeks industry participants to take part in evaluating the agency's electronic personal conferencing system ("The Gray Sheet" April 17, p. 4). Currently under trial within the center, the system "enables two people, at remote locations, to see and hear each other while reviewing and/or editing the same document shown on both computer screens" and allows "for the transmission of voice, video, and data displayed in a Windows application over a single communication link," FDA explains. In the next phase of testing, the agency plans to use the system in conjunction with device sponsors to "interactively and simultaneously discuss and modify documents which relate to new device applications," such as investigational device exemption protocols, deficiency letters, data summaries or labeling. For further information, contact Office of Information Systems Director Neil Goldstein at 301/594-4585...