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FDA to seek public comment on recommendations to the 510(k) program
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FDA has announced that it will open a public docket and receive public comments in response to a report from the Institute of Medicine on the 510(k) program.
The FDA commissioned the Institute of Medicine (IOM) report in September 2009 in response to concerns raised by its stakeholders. The report was part of efforts to determine what — if any — changes should be made to improve the 510(k) program. None of the IOM’s recommendations are binding, but the FDA plans to hold a public meeting in the near future to foster discussion.
“We appreciate the IOM’s report on the 510(k) program, and agree that the public should continue to feel confidence in the medical devices on the market today,” FDA Center for Devices and Radiological Health Director Jeffrey Shuren, MD, stated in an FDA release. “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.”
The statement also noted that while the FDA believes the 510(k) process should not be eliminated, it is open to additional proposals and approaches for improvement of the device review program.
According to an FDA release, the 510(k) program is the most common pathway to market for lower-risk medical devices. In order for a manufacturer to begin marketing a device subject to 510(k) review, the FDA must clear a 510(k) premarket notification demonstrating the new or modified product is substantially equivalent to another legally marketed “predicate” device.
Congressional action will be required if some of the IOM’s recommendations — such as the design of a new regulatory framework for class II (moderate risk) devices — are to be followed, but the FDA noted in the release that it plans to continue its review of the report and further solicit input from stakeholders regarding recommendations in the report that involve existing FDA authorities.
According to the release, the FDA has also committed to a plan designed to improve the 510(k) program and other device review programs.
“Many of the IOM findings parallel changes already underway at the FDA to improve how we regulate devices,” Shuren stated. “These actions, plus a sufficiently funded device review program, will contribute to a stronger program.”
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