It's Official: Jeffrey Shuren Is New Device Center Director

Full article reprinted from "The Gray Sheet" - January 25, 2009

FDA and Jeffrey Shuren have made it official: the neurologist, lawyer and experienced FDA staffer was named director of the agency's Center for Devices and Radiological Health Jan. 20. Read more...

Full article reprinted from "The Gray Sheet" - January 25, 2009

It's Official: Jeffrey Shuren Is New Device Center Director

FDA and Jeffrey Shuren have made it official: the neurologist, lawyer and experienced FDA staffer was named director of the agency's Center for Devices and Radiological Health Jan. 20.

Shuren, who has been acting director since September, was permanently hired for the post the same day the center released an ambitious agenda for the coming fiscal year that includes several projects in which Shuren is already actively engaged.

Shuren replaced former center director Dan Schultz, who resigned last August in the midst of the new FDA administration's reassessment of pre-market review practices. Schultz, who served a five-year stint at CDRH's helm, is now a consultant with Greenleaf Health (The Gray Sheet' Jan. 11, 2010).

Shuren A Shoe-in?

Though FDA launched a national search for Schultz' replacement last fall, Shuren was an early favorite for the job (The Gray Sheet' Oct. 19, 2009).

FDA notes that Shuren played a leadership role in a number of agency initiatives over the years, including the reauthorization of the Medical Device User Fee Act in 2007 and the creation of the Sentinel Initiative, a safety surveillance network FDA is developing to integrate post-market data on drugs and, eventually, devices.

Device trade association AdvaMed applauded Shuren's appointment in a Jan. 20 statement.

AdvaMed President and CEO Steve Ubl noted that, as a key negotiator on the user fee legislation, "Dr. Shuren demonstrated he understands the unique needs of the medical technology industry."

Even some of CDRH's harshest critics agreed it was a "wise choice."

"He's clearly set CDRH on a more public health path than it had been on previously," said Diana Zuckerman, president of the National Research Center for Women and Families. "He's taking the criticisms of the center seriously."

At CDRH, Shuren Hit The Ground Running

Shortly after joining CDRH last fall, Shuren announced his six top priorities for the center. They included reviewing the 510(k) program, learning how FDA can adapt to changing technology while providing a predictable regulatory pathway, and establishing better dispute resolution procedures.

Shuren also co-authored an internal evaluation of FDA's handling of the controversial Menaflex knee implant (ReGen Biologics) 510(k) clearance, which unearthed shortcomings in CDRH's pre-market review process (The Gray Sheet' Sept. 28, 2009).

Mark DuVal, an attorney who represents device firms before the FDA, says Shuren's handling of the ReGen report is a mostly promising sign for industry.

"I read some fairly balanced comments and some insightful takes on the agency itself [in the report]," DuVal said. "There are some things I take issue with, but by and large I thought he dug in and had a pretty good look at the center he was about to run."

But frequent FDA advisory panel member and agency critic Steven Nissen stressed that Shuren has an uphill climb ahead. "He is taking over a division of the FDA that is extremely troubled and [that] has made a number of bad decisions over the last years," the Cleveland Clinic Foundation cardiologist said in an interview.

"It is going to be very important for Dr. Shuren to reverse the course of CDRH and turn it into more of a public-health-oriented segment of the agency," Nissen said. "He will need to do some things fairly quickly to gain the confidence of the medical and scientific community."

Shuren joined the agency as a medical officer in the Office of Policy in 1998, then left in 2001 to become director of the items and devices division in CMS' Coverage and Analysis Group.

He returned to FDA in 2003 as assistant commissioner for policy, and became associate commissioner for policy and planning in 2008.

- Jessica Bylander

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