FDA Backs Quicker Reviews for Implants in Reply to Report

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.