CDRH Chief: Drug-Eluting Stent Guidelines on the Way

-FDA News

03/27/2008 - A long-awaited guidance on drug-eluting heart stents is imminent, CDRH Director Daniel Schultz says.

The guidance, which should come out in the next few weeks, will address questions about the stents’ safety compared with bare-metal stents, Schultz said at a recent media round table.

The agency is working with companies to improve studies for these stents and wants broader patient experience in premarket trials and simple postmarket studies. “The amount of early adoption of drug-eluting stents took everybody by surprise,” Schultz said.

He added that the agency needs to strengthen the postmarket piece of the puzzle to understand when problems with devices will arise and learn lessons for designing the next generation of devices.

One way to strengthen postmarket regulation is to improve the way the agency receives and analyzes reports. Two years ago, the FDA began examining this process to identify gaps and opportunities for improvement. The centerpiece of CDRH’s postmarket transformation initiative is a “medical device matrix,” Schultz said. The agency is working toward this by creating product networks that cut across functional units of the center.