“All metal-on-metal implants were approved under FDA’s 510(k) process, in many cases without clinical data,” Harkin said. “Today there are half a million Americans walking around with a dangerous hip implant and few options.”

Jeffrey Shuren, MD

Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health (CDRH), defended 510(k), even for complex implantable devices. “In some cases, it does make sense for an implantable device to be considered through 510(k) if it truly is moderate risk,” Shuren said. “And sometimes we know that up-front. Sometimes we learn over time about that risk and, what was previously a high-risk device, we make it a low-risk device. Our law is based upon taking risk into consideration in terms of applying what our requirements are, and we take it very seriously.”

Shuren admitted this process is based on the judgment of FDA reviewers, rather than hard, clinical data, and that the process failed in the case of metal-on-metal hip implants. “We, under the least burdensome principle, decided that we weren’t going to ask for clinical data in this case. And these were always trade-offs and judgment calls as we try to figure out what the least justified burden is to impose on the company. That’s a scientific decision, and sometimes we slide to a place and it’s not the right call,” Shuren said. “There were failures [in the hip implants] that we might have detected if we had asked for other kinds of information.”

High Turnover in CDRH

Many of the problems with 510(k) are not with the program itself but with a lack of resources, Shuren said.

The No. 1 problem identified by FDA was insufficient predictability in the review process, which has several root causes. The first is a very high reviewer and manager turnover at CDRH — almost double than that of FDA’s centers for drugs and biologics. That high turnover rate results in insufficient reviewer training and insufficient oversight by managers, Shuren told legislators.

“Almost half of my reviewers have four years of experience or less,” Shuren said. Experience is even less for front-line managers — a turnover rate that disrupts the review process.

“There is also not enough management oversight,” Shuren said. “Sometimes the ratio of reviewer to manager is as high as 27 to 1.”

Some of these personnel issues could be addressed through higher user fees, Shuren testified. Currently FDA is working with Congress and industry to reauthorize the Medical Device User Fee Act (MDUFA). Fees for medical device applications are significantly lower than fees for new drug applications.

The savings to industry generated by the quicker, safer and more efficient review process resulting from more resources would outweigh any reasonable increase in fees, Shuren said.

However, Shuren would not respond in depth to the IoM report. FDA was still getting administration approval of its official response, and so he was “hamstringed,” Shuren said.

Asked why the agency rejected the report’s core conclusions, Shuren said, “We think the 510(k) program, in most cases, has worked well. If we’re going to be [replacing it], I’d ask what are we putting in its place. It’s a question the Institute of Medicine felt they were not in a place to actually say. To get rid of the program would be highly disruptive. And what are we gaining in return? Do we have an alternative program that can assure safety and effectiveness and can do a better job then what we’re doing right now?”

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