FDA Backs Quicker Reviews for Hip Implants in Reply to Panel’s Report (Bloomberg)
A program allowing U.S. regulators to approve moderate-risk medical devices in an average of 10 months instead of years shouldn’t be scrapped, the Food and Drug Administration said in response to an advisory panel report.
The Institute of Medicine, asked by the agency to review the program, urged the FDA today to abandon use of the so-called 510(k) process to clear a class of devices that include orthopedic implants and x-ray machines. The system is used to evaluate products similar to those already cleared, or about 90 percent of applications. The FDA said it would put the institute’s recommendation up for public comment.
“We are open to additional proposals and approaches for continued improvement of our device review programs,” said Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health, in a statement.
The FDA should direct device makers such as Johnson & Johnson (JNJ) to prove each moderate-risk, or Class 2, product is safe and effective on its own merits, the institute said today. The report, which isn’t binding, follows by a month a Government Accountabil...
