FDA medical device chief Schultz resigns

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Daniel G. Schultz, MD, announced his resignation Tuesday as director of the FDA’s Center for Devices and Radiological Health (CDRH), a position that he has held since 2004. Schultz has worked at the agency for the past 15 years.

Jeffrey Shuren, the FDA’s assistant commissioner for policy, will serve as acting CDRH director.

The Wall Street Journal reported that Schultz’ decision is a "mutual agreement" with FDA Commissioner Margaret A. Hamburg, MD, who took office in May, under an Obama Administration appointment. An FDA spokesman told the Journal that Schultz's decision came as the result of talks with Hamburg, and had nothing to do with any specific issue related to a device's approval process.

However, nine FDA device division employees wrote to the House Energy and Commerce Committee in October 2008 to complain that the division's leaders had approved devices despite formal safety and efficacy concerns raised by FDA, the Journal reported. At the time, the FDA declined to comment.

“As CDRH director, Dan was instrumental in crafting the historic agreement in 2007 reauthorizing medical device user fees, which has provided FDA’s device program with a stable source of funding to help meet its regulatory responsibilities,” said Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (ADVAMED). “We wish Dan all the best in his future endeavors and look forward to working with Acting CDRH Director Jeff Shuren as the search for a permanent director of the device center proceeds.”