FDA Urged to Review Medical Device Approval Process

Medical experts in the United States have said that the approval for medical devices by the Food and Drug Administration is flawed and asked the agency to review its approval system of new devices. National Academy of Sciences’ Institute of Medicine came up with a new report in which it criticized the fast track approval process, known as 510(k), of new devices by the FDA and said that the agency is not able to fully evaluate the safety and effectiveness of the device.

However the FDA has rejected the recommendation though the agency’s director of Center for Devices and Radiological Health, Dr Jeffrey Shuren said that the agency welcomed new suggestions.

“FDA believes that the 510(k) process should not be eliminated, but we are open to additional proposals and approaches for continued improvement of our device review programs”, he said.

Source-Medindia