FDA to Seek Public Comment on IOM Recommendations
SILVER SPRING, Md., July 29, 2011 /PRNewswire-USNewswire/ -- The FDA today announced that it will open a public docket to begin receiving public comments on the Institute of Medicine's (IOM) report on the 510(k) program, the most common pathway to market for lower-risk medical devices.
The FDA commissioned the report in September 2009. While none of the IOM's recommendations are binding, the FDA is planning a public meeting in the coming weeks to discuss recommendations made in the report, titled "Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years."
"We appreciate the IOM's report on the 510(k) program, and agree that the public should continue to feel confident in the medical devices on the market today," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health.
"Medical devices in the U.S. have a strong track record of safety and effectiveness. The 510(k) program has helped support a robust medical device industry in the U.S. and has helped bring lower-risk devices to market for the patients who need them."
"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," Shuren said.
In order for a manufacturer to begin marketing a device subject to 510(k) review, FDA must "clear" a premarket notification (510(k)) demonstrating that the new or modified product is substantially equivalent to another legally marketed "predicate" device.
Some of the IOM's recommendations, such as the recommendation to design a new regulatory framework for Class II (moderate risk) devices, may require congressional actions. However, the FDA plans to continue its review of the report and to solicit input from stakehold