FDA Seeking Input on 510(k) IOM Report

FDA is asking for public comments on the Institute of Medicine’s (IOM) new report, “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years.” FDA commissioned the report in September 2009.

“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, in a statement published on FDA's Web site. “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 added.

According to FDA, "a 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to [premarket approval]. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims."

In its press release, FDA states that "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 stakeholders regarding the recommendations in the report involving existing FDA authorities."

FDA has already begun to update its 510(k) program. It has just issued draft guidance clarifying when manufacturer changes to a 510(k)-cleared device already on the market warrant a new 510(k) submission.

Expected changes include a draft guidance on the “de novo classification” path to market for novel low and moderate risk devices that are not substantially equivalent to an existing device as well as draft “510(k) Paradigm” guidance clarifying certain aspects of FDA’s 510(k) substantial equivalence review.

FDA is also expected to propose a rule on Unique Device Identifiers. According to FDA, the IOM noted that UDI would be a meaningful change to the agency’s postmarket capability.