SAN FRANCISCO — The annual FDA town hall meeting at TCT offers the occasional zinger, but for the most part is a fairly pedestrian event. This year's town hall meeting included a remark by a prominent cardiologist that the time may be ripe for a conditional device approval mechanism, and the director of FDA's Office of Device Evaluation commented that such a thing might not be legal at present. However, ODE director Christy Foreman indicated no opposition, stating that the next device user fee negotiations "will be an opportunity for legislative changes." However, "what we really need is the data," Foreman said, so FDA can make the argument "if Congress asks." Read More
