(FDA: Silver Spring, MD) -- The FDA has 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. Although 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,” says Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “Medical devices in the United States have a strong track record of safety and effectiveness. The 510(k) program has helped support a robust medical-device industry in the United States and has helped bring lower-risk devices to market for the patients who need them.

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