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

June 22, 2010 by MassDevice staff

Dr. Jeffrey Shuren, head of the Center for Devices & Radiological Health, tells a Woburn, Mass., town hall meeting that a report on the Food & Drug Administration's internal review of the 510(k) process is due within the next several weeks.

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.