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.
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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
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