CDRH’s Shuren: FDA’s 510(k) findings due soon

Dr. Jeffrey Shuren, head of the Food & Drug Administration’s medical device oversight arm, told a Massachusetts audience that results from the agency’s internal, soup-to-nuts review of its 510(k) clearance program are due out in a few weeks.

At the second in a series of "town hall" meetings in Woburn, Mass., the Center for Devices & Radiological Health’s leader said the federal watchdog would seek public comment on the report before making any changes to the program.

Shuren told MassDevice that the agency still hasn’t decided exactly what changes are in store for the 510(k) process.

"What we’ve been saying so far is not anything about what changes we’re going to make. There’s a lot of rumor mill about what we’re going to do, but we’ve not said we’re doing A, B, C or D specifically," he told us. "The only thing I’m very clear about is we’re not recommending to get rid of the 510(k) program."

Asked if the Obama administration is advocating for more stringent oversight of medical devices, Shuren said his department has been given free rein to police the industry as it sees fit.

"I have had absolutely no pressure or pushback from the administration. Even the commissioner of FDA, has, I think much to her credit, let the center do its own assessment, come back with its own recommendations," Shuren said. "I can tell you the things that we want to put out for the public have her full support in moving forward."

The FDA’s internal 520(k) review includes the feedback generated at the town hall meetings, Shuren said, as well as examinations of the agency’s database and a survey of its review staff and managers.

"I think one of the challenges for both industry and FDA on the 510(k) is that there have not been tools — very good metrics — put in place to access the effectiveness of the program. That’s something that needs to be addressed in the future. There’s been a lot of discussion, for example, of, "Well, we’re not seeing a lot of people dying across the country from medical devices on the market," he said. "Well, actually, people do get hurt by medical devices, but on the flip side no device is risk-free. The question is, were these anticipated risks and have we taken appropriate steps to mitigate to the extent we can? Nothing is going to be risk free.

Jeffrey Shuren

CDRH head Dr. Jeffrey Shuren

"The real test of the program is whether or not, when we’re making a decision for a device to go on the market, there are truly reasonable assurances of safety and effectiveness. That’s what the standard is — not whether a device made it on the market and it turned out to be unsafe," Shuren said. "The FDA is there to check to make sure it’s safe and effective before it goes on the market. It’s either safe and effective or it’s not before it’s coming to us. The same with medical devices. And that’s the real test of the 510(k) program and how it’s implemented. Is it good enough and are we implementing in a way that when a device gets on the market there truly are reasonable assurances of safety and effectiveness?"

To that end, he said, some companies applying for 510(k) clearance will be asked to submit more clinical data than in the past.

"Those decisions are case-by-case, based on the device. What we will try to address is, can we be more clear about when we would anticipate clinical data for a device?" Shuren told us.

Touching on the high-profile controversy over the FDA’s clearance of ReGen Biologics Inc.’s (OTC:RGBO) Menaflex knee cartilage implant, Shuren said that foofaraw wasn’t behind the scrutiny of the 510(k) protocol.

"A lot of people have asked did we do this over ReGen. The answer is no," he said "These issues we uncovered in 510(k) were circling around for a while."

Citing the programs origins in 1976, Shuren said the agency has tried over the years to adapt it as a path to market for lower-risk medical devices.

"FDA has tried to be flexible to squeeze through as many devices as possible, [but] as technology evolves it’s not as adequate," he said. "It’s not the first time we’ve done [a review] and it probably won’t be the last time. The world will change and we have to make appropriate mid-point adjustments."

In his opening remarks, Shuren said the message from the medical device industry has been consistent on one subject: The need for predictability along the regulatory pathway.

"I have heard a clear message from you: The FDA needs to provide industry with clear, predictable pathways to approval and clearance. We hear you. We agree. And we’re on it," Shuren said. "Providing clear, predictable pathways to market will also help foster innovation, which is the other theme we’ve been hearing. We agree with you on this front, as well."

To that end, he said, the agency is putting "concrete step we can take to be a smarter FDAs" into its strategic priorities for 2010.

"One such step is to make available our experts to help industry solve problems, not just identify them," Shuren explained. "For example, we’ve been collaborating with the University of Pennsylvania on open-source software for external infusion pumps that manufacturers can build on or use to benchmark their own products. In fact, we’ve offered to perform diagnostics on infusion pump software at any stage of development — even before the device lands at our doorstep."

More than 500 people attended Shuren’s first town hall meeting May 18 in Minneapolis, he said, noting that a scheduled town hall meeting in Los Angeles in October would be his last this year.

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