UPDATE: CDRH Director Resigns

Daniel Schultz, director of the Center for Devices & Radiological Health (CDRH), is resigning, according to the U.S. Food and Drug Administration (FDA).

In an e-mail announcement, FDA Commissioner Dr. Margaret Hamburg said, “Today, Dr. Daniel Schultz announced his resignation as director of the Center for Devices and Radiological Health (CDRH). I would like to take this opportunity to thank him for his long service to the agency and tothe public. Dan has worked tirelessly to advance the public’s healththrough the approval and monitoring of innovative and safe medical devices.”

She added: “Under Dan’s leadership, CDRH enhanced our understanding of the risks and benefits of using medical devices in pediatric populations, increased the agency’s safety efforts by expanding MedSun, and led the agency in the postmarket transformation process, which has provided an opportunity to fundamentally rethink the way risk/benefit information is collected, analyzed and executed.”

Dr. Jeff Shuren will serve as acting CDRH director upon Schultz’s departure. Shuren is board certified in neurology and served as an assistant professor of neurology at the University of Cincinnati in Cincinnati, Ohio.In 1998, Shuren joined the FDA as a medical officer in the Office of Policy. In 2001, he became the director of the Division of Items and Devices in the Coverage and Analysis Group at the Centers for Medicare and Medicaid Services. He returned to the FDA as the assistant commissioner for policy in 2003, and assumed his new position as associate commissioner for policy and planning in 2008.

The Washington, D.C.-based Medical Device Manufacturers Association, in a statement, said, “MDMA has appreciated working with Dr. Schultz over the years to provide patients with timely access to safe and effective products and wish him the best.”

Stephen Ubl, president of the Advanced Medical Technology Association, said in a statement,“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. In addition, he launched CDRH’s postmarket transformation initiative, which is designed to improve the collection, analysis and utility of the agency’s multiple sources of postmarket medical device data. Dan also has been a leader in efforts to strengthen and harmonize global medical device regulatory requirements and has supported FDA’s work on the Global Harmonization Task Force.”

Schultz joined the FDA in April 1994 as a medical officer in the general surgery branch of CDRH. He went on to become chief medical officer in the Division of Reproductive, Abdominal and Radiological Devices. He later served as division director, and then as deputy director and director of the Office of Device Evaluation in CDRH.