FDA Commissioner Margaret Hamburg recently called CDRH “clearly troubled” and said that a formal review of the 510(k) process is underway. At the Reuters Health Summit in New York City, she said that people in the medical industry have voiced concern over the confusion related to 510(k) procedures and that this confusion was also negatively affecting investors. “I was hearing from investors that unless there was a more explicit definition of standards and expectations, that it was increasingly unattractive to them to be investing in the medical device area,” she said. “We are working on some important issues that will benefit industry and benefit the ultimate outcome of our regulatory procedures.”

Hamburg also mentioned that FDA is currently in the process of hiring a new head of CDRH.