U.S. FDA devices chief steps down

U.S. FDA devices chief steps down

The head of the U.S. Food and Drug Administration's device center stepped down on Tuesday, a move that follows a raft of scandals over safety recalls, concerns over the agency's device approval process and other controversial issues.

Daniel Schultz, who served at the agency's Center for Devices and Radiological Health for 15 years, resigned after reaching an agreement with FDA Commissioner Margaret Hamburg "that my stepping down at this time would be in the best interest of the center and the agency.

"His departure follows a string of problems at the center, such as recalls of various products including those made by top device makers Medtronic Inc and Boston Scientific Corp thought to have met certain standards.

Agency scientists have also complained about pressure from top managers at the device center.

In a separate letter to FDA staff, Hamburg said she had appointed Jeff Shuren, the agency's current associate commissioner for policy and planning, to lead the device center on an acting basis.