Dr. Margaret Hamburg, Commissioner of Food and Drug Administration (FDA) said that she is working to reconstruct the issues within the agency's troubled device unit Center for Devices and Radiological Health (CDRH), including a review of the 510(k) process to approve medical devices, the Reuters reported.
Margaret Hamburg said the device unit was “clearly troubled” and it was immediately clear to her that big changes were in order.
She said: “We are working on some important issues that will benefit industry and benefit the ultimate outcome of our regulatory procedures, including making sure we have a robust internal review process.”
She said a formal review of the 510(k) process — which is used for reviewing most medical devices approved by the agency such as sutures and intravenous administration sets and is less stringent than the FDA’s pre-market approval process used in reviewing high-risk devices — was under way.
Hamburg said she had heard from people in the medical device industry, from medical groups and medical professions, who were complaining about the confusing nature of some of the system’s requirements.
“And 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.