Senate 510(k) Hearings Flawed, Device Attorney Says

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Michael Causey, Editor & Publisher,

Calling the recent GAO charges that the FDA is putting patients at risk by approving too many devices through the 510(k) process “silly and off base” leading medical device industry attorney Jonathan Kahan, Co-director of law firm Hogan Lovells’ Medical Device practice which represents about 700 medical device firms, says the current climate of misguided regulation is as bad for device firms as it was in the early 1990s.

Small device firms in particular are struggling to understand FDA’s confusing regulatory posture, and many are going out of business as a result, Kahan told us April 18. Kahan  has been practicing in FDA law for 35 years, and specifically focuses on assisting medical device companies navigate the FDA’s regulatory process.

During high-profile Senate  hearings last week the FDA heard from lawmakers that no one is especially thrilled with the agency’s performance in this arena  As reported in the Minneapolis Star-Tribune,  “Nobody is particularly happy with the FDA,” Sen. Bob Corker, R-Tenn said at the hearing.

Kahan acknowledges that some medical devices fail (“and NASA can’t always make a shuttle that doesn’t blow up”), but he stressed that the numbers are very low and that the GAO report wouldn’t address those failure problems anyway. “The problems occur more in the manufacturing side and not as a result of the 510(k) process,” he said.

“Congress and the White House have an astounding lack of understanding of this issue,” Kahan added. “The GAO emphasis is totally missing” the point.

Kahan stressed that the biggest issue is FDA inconsistency in its regulations and enforcement policy. He was echoed by at least one speaker at last week’s hearings.

The medical device industry is concerned that CDRH procedural and management problems have slowed medical device innovation. In his testimony last week, David Nexon, Senior Executive Vice President of the Advanced Medical Technology Association, criticized that there are, “inefficiencies at FDA that delay patient access to new treatments and cures and erode U.S. global competitiveness in the development of medical technology.”


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