In September 2009, the United States Food & Drug Administration (FDA) commissioned a report from the Institute of Medicine (IOM) on the current 510(k) pre-market approval process, the most common pathway to market for lower-risk medical devices. The FDA undertook the assessment in response to concerns raised by various stakeholders in an effort to determine what, if any, changes should be made to improve the program and update it so that it adequately addresses the level of current device complexity and today’s marketplace.
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.
“Many of the IOM findings parallel changes already underway at the FDA to improve how we regulate devices. These actions, plus a sufficiently funded device review program, will contribute to a stronger program,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “Any major modifications made to the agency’s premarket review programs should be based on sound science and through thoughtful and transparent discussion.”
The FDA plans to continue its review of the report and today announced that it will open a public docket to begin receiving public comments on the IOM report and the 510(k) program. The FDA is also 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.”
“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,’ said Dr. Shuren. “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.”
Clinicians and manufacturers who would like to submit comments on the IOM report or the current 510(k) program can do so electronically through http://www.regulations.gov or by mail. Send written comments to:
The Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
Comments must include the docket number [FDA-2011-N-0556] and be submitted by September 30, 2011.