FDA to seek public opinion on Institute of Medicine’s 510(K) recommendations

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The Food and Drug Administration (FDA) announced that it will open a public docket to begin receiving public comments on the recently published Institute of Medicine’s report on the 510(k) programme.

In response to concerns raised by various stakeholders, the FDA commissioned assessment of its 510(k) programme to the Institute of Medicine of the National Academies of Science.


While none of the Institute of Medicine’s recommendations are binding, the FDA is planning a public meeting in the coming weeks to discuss recommendations made in the report: “Medical devices and the public’s health: The FDA 510(k) clearance process at 35 years.”


“We appreciate the Institute of Medicine report on the 510(k) programme, and agree that the public should continue to feel confident in the medical devices on the market today,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.


“Medical devices in the USA have a strong track record of safety and effectiveness. The 510(k) programme has helped support a robust medical device industry in the USA 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 programmes,” Shuren said.


Some of the Institute of Medicine’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 stakeholders regarding the recommendations in the report involving existing FDA authorities.


“Many of the Institute of Medicine findings parallel changes already underway at the FDA to improve how we regulate devices. These actions, plus a sufficiently funded device review programme, will contribute to a stronger programme,” said Shuren. “Any major modifications made to the agency’s premarket review programmes should be based on sound science and through thoughtful and transparent discussion,” he added.