FDA names permanent chief of devices unit
WASHINGTON (Reuters) - The U.S. Food and Drug Administration has named Dr. Jeffrey Shuren permanent director of its medical devices division which has been criticized for product recalls and controversial approvals in recent years.
Shuren had served as acting head of the unit, which reviews products such as implanted heart defibrillators and artificial hips, since previous chief Daniel Schultz resigned in August 2009.
FDA Commissioner Margaret Hamburg appointed Shuren to the job on a permanent basis on Wednesday, agency spokeswoman Mary Long said.
Hamburg had said she was cleaning up problems in the division before Shuren took the acting post. Issues that have drawn scrutiny in recent years include recalls of products from top manufacturers such as Medtronic Inc and Boston Scientific Corp.
Agency scientists also complained about pressure from top managers, and congressional investigators found shortcomings in the process for approving some riskier devices.
The Institute of Medicine is studying a fast-track approval process for certain devices, and Hamburg has ordered an internal review.
Shuren has held various FDA posts since 1998 including associate commissioner for policy and planning. In a previous job, he oversaw development of Medicare's national coverage decisions for medicines and non-implantable devices.
The device unit's priorities for 2010 will include strengthening product reviews and increasing transparency about decision-making, according to documents posted on the FDA website here
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