FDA device chief resigns

August 13, 2009

The director of the FDA Center for Devices and Radiological Health, Daniel Schultz, stepped down earlier this week amid allegations that he inappropriately exerted pressure on reviewers to approve devices for the U.S. market.

FDA device chief resigns
The director of the FDA Center for Devices and Radiological Health, Daniel Schultz, stepped down earlier this week amid allegations that he inappropriately exerted pressure on reviewers to approve devices for the U.S. market. FDA Associate Commissioner for Policy and Planning Jeff Shuren will step in as interim CDRH director.Schultz, who became CDRH director in 2004, came under fire after nine scientists wrote to the Obama administration transition team complaining they were pushed to approve faulty medical devices. In a letter to agency staffers, Daniel Schultz said he and FDA Commissioner Margaret Hamburg agreed his resignation "would be in the best interest of the center and the agency," according to the Associated Press. Hamburg was appointed by President Obama to restore the FDA’s credibility, which has suffered recently with drug recalls, such as the pain reliever Vioxx, and illnesses due to food poisoning.