FDA’s Device Chief Responds to Industry’s 510(k) Concerns

Jeffrey Shuren, M.D., director of the Center for Devices and Radiological Health has been a one-man public relations machine lately. There’s no doubt he hit the ground running since taking the helm of the U.S. Food and Drug Administration’s (FDA) device office nine months ago, but the push for positive spin and dialog has increased as the pressure also has grown regarding the agency’s 510(k) clearance program—not to mention the industry’s uncertainties surrounding the present and future shape of the review and submission processes.

He’s hit the road recently, with a town hall meeting in Minneapolis last month and upcoming trips planned for Massachusetts later this month and California in October. One of Shuren’s most recent stops was the annual meeting of the Medical Device Manufacturers Association (MDMA) in Washington, D.C. CDRH directors are no strangers to MDMA’s annual gathering, however, Shuren’s “presentation,” if you can call it that, was less podium and PowerPoint and more relaxed conversation talk-show-host style. He made brief remarks before strolling the ballroom lined with tables, microphone in hand, answering device makers’ questions.

His primary message? The 510(k) program isn’t going anywhere.

“First off, nobody’s going to scrap the 510(k) program. There’s a lot of value to the program,”he pointedly told the audience from the outset of his comments. “For the most part, the issues we’re encountering are for a smaller subset of devices. There are some broad issues, but for the most part, the challenges with devices pertain to a smaller minority. Most of the devices we deal with, at least form our perspective, just aren’t issues. The 510(k) program works very well.”

Shuren, a neurologist who also holds a law degree, did acknowledge that there has been “angst” regarding the program.

“We have heard concerns about the 510(k) program, although it has ratcheted up from what we hear and even from our own perceptions,” he said, adding that the concern, among other issues, led to an internal review and external analysis by the Institute of Medicine (IOM), which is expected next year.

“The value of [the IOM review] is that it is an assessment independent of FDA,” he explained, but said the results of an internal review of the 510(k) program also will provide clarity. “First, as a federal agency, we had an obligation to do self reflection and go back and look at our own programs. Secondly, 2011 is a long time. If there are things we should be doing now, we need to get those things underway before 2011.”

He acknowledged that the agency is moving very quickly and that some people in the industry have voiced their concerns that the process of “introspection” may moving too quickly. Even Shuren’s own CDRH staff have shared their concern about the pace of possible change.

“I’m asking a lot of them and myself. And I’m asking for patience and understanding, but the concerns are so great that waiting a long time does not serve the interest of anyone,” he said, adding that they’re trying to get as much information as possible and digest it quickly and come out with preliminary [510(k)] recommendations in a report expected to be released later this summer. “

Industry feedback to the internal findings will be solicited, and, if possible, debated and implemented before the end of the year.

An ongoing criticism of the CDRH review proces—both for 510(k)s and premarket approval—is a lack of consistency and predicability.

Shuren acknowledged that the agency could be “a little more clear” when its expectations change. The agency also has begun an internal review of that process as well, he said.

“What should we base those decisions on, and how do we communicate them?” he asked. For example, at present, if the agency determines that there’s new safety information for a device, and it needs to amend the kind of assessment that is expected from the device sponsor, getting the message out to device companies isn’t always direct or efficient.

“How do we communicate it? Well, now we tend to do it on an ad-hoc basis,” Shuren admitted. He said companies may not find out until they visit or call the agency prior to submitting a device application. If a company already has a device in clinical trials, it may not find out about the new requirements until it has made its submission.

“That can lead to long delays and money spent,” Shuren said. “It doesn’t serve you well or us well. Another way is to issue a draft guidance, but this is resource intensive. There is a better way.”

Along with the internal 510(k) review, CDRH officials also are examining other ways to communicate such decisions more effectively. Shuren said a report on findings will come out “around the same time” as the 510(k) report this summer.

Much of this activity is part of Shuren’s attempts to “change the culture” in the CDRH, he said.

The mission of CDRH that Shuren articulated is to promote public health by helping safe and effective technologies to market, but it also has another side. Promotion of innovation is “a piece I found missing” he said.“For example, what can we do to help facilitate design changes that will reduce those risks? Why are we waiting for industry to go out and solve problems? What can we do to bring internal expertise to problems? We need to make our internal expertise available.”As an example, Shuren referenced a new initiative on infusion pump safety and monitoring launched by the agency in late April.

A new council on medical device innovation is another priority for FDA, according to Shuren. The council will have participation from several government agencies, including the National Institutes of Health (NIH), the Centers for Medicare & Medicaid Services (CMS), the Centers for Disease Control and Prevention, the U.S. Department of Veterans Affairs, and the U.S. Department of Defense. Earlier this year, such an initiative was announced, but only included the FDA and NIH. A public workshop on the expanded program will be held on June 24 outside Washington, in Gaithersburg, Md., to gain insight from multiple industry stakeholders.

“This is all focused on where we think the greatest need may be,” he said, adding that different agencies will work together to examine where new medical technology might have the greatest impact on public health. “We would also look at reducing barriers to entry, for example where roadblocks could be reduced, for example at CMS or FDA.”

Shuren compared his role at CDRH to that of a medical device CEO, noting that he manages a “company” with more than 1,300 employees—much larger than most medtech firms. And like his fellow CEOs, he needs current and frequent intelligence.

“If I’m going to run this ‘business,’ I need to know what’s going on. I need signals, red flags,” he said, in order to address industry needs. He urged the audience to make an effort to stay in touch with CDRH, noting that open communication would be key to success of the initiatives currently being debated, though he recognized how trite that bit of advice sounded.

“We have to get past this fear; we honestly have to get past it,” he said. “If there are problems, you need to tell us. I get lots of anecdotal stories. I only occasionally get someone who actually comes to the door and discusses a problem with a product so we can fix it and learn from it. We need the ability to have that dialog.”

Shuren told his audience that it’s not an easy process, but there’s no alternative.

“I’ve got a friend who is a professional hockey coach. There’s an old saying in hockey that you skate to where the puck is going to be,” he said. “In our business, skating to where the puck already is can be a challenge. We need to get to where it’s going to be.”