FDA’s Shuren says new 510(k) survey is informative, but limited in scope

A new survey critical of the U.S. Food and Drug Administration’s 510(k) review process makes important suggestions for improvement, but is not representative of the industry as a whole.

That was the response of Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, who participated in a panel Tuesday to discuss results of the survey that portrays the agency’s pre-market notification process as slow, unpredictable and damaging to U.S. innovation and global competitiveness. It also showed that smaller companies overwhelmingly choose Europe as the first venue to introduce their products and delay product introductions in the U.S.

Shuren pointed out that the survey undertaken by Northwestern University researchers only polled 356 individuals out of at least 5,000 device companies in the U.S., with multiple responses allowed from the same company. In other words, “less than 10 percent of industry responded to the survey and fewer still responded to specific questions,” Shuren noted.

He added that the survey found a significantly higher percentage of companies required to furnish clinical data with their 510(k) submissions, something that was much lower in the entire universe of 510(k) submissions to the FDA. However, he did not provide that lower percentage figure.


Shuren found fault with the subjective nature of the survey as well.

“For example, responses to whether or not FDA questions were considered scientifically justified is not only subjective, but small companies that have far less experience with FDA requirements tended to believe FDA questions were unjustified more often than large companies,” he said.

Despite taking issue with the methodology of the survey, Shuren described it as “informative.” He also acknowledged problems at the FDA — including high staff turnover and the need to be more predictable.

“It is critical to reduce the unacceptably high turnover rates at CDRH if we are to provide the kind of predictability that we and industry want to see in that program,” he said.

But Shuren rejected the notion that FDA reviewers were asking more questions unnecessarily, one cause contributing to unpredictability, according to companies.

“It’s not science for science’s sake,” he said. “While any unnecessary data request from FDA is a concern to us and some of them (identified in internal analyses) in fact were, the rate is significantly less than suggested by survey responses.”

At one point in the panel discussion after his prepared remarks, Shuren responded to that complaint of unnecessary data request by arguing that sometimes the agency has information that companies may not be privy to. But he did not expand on that.

Still, in his prepared response, he took some of the blame for the perception that the agency asks too many unnecessary questions. It’s the result of “inadequate guidance and inadequate communication by CDRH,” Shuren said. The agency is working to resolve those by preparing seven guidance documents that the FDA committed to completing this year.

Other panelists gathered at the Washington, D.C. event were Susan Alpert, former senior vice president and chief regulatory officer, Medtronic; Peter Barton Hutt, senior counsel at Covington & Burling; and Philip Phillips, president of Phillips Consulting Group.

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