The U.S. Food & Drug Administration (FDA) has proposed new guidance that could significantly change certain aspects of the agency’s 510(K) clearance program. Among other things, the new draft guidance would require device manufacturers to determine whether alterations to a previously-approved product could impact its safety and effectiveness.
The FDA’s 510(K) clearance program allows a new device to come to market without undergoing human clinical trials, so long as a manufacturer can demonstrate that it is “substantially equivalent” to a previously approved product. The program’s original guidelines were established in 1997, and were intended to cover low-to-moderate risk devices, such as blood pressure cuffs and hypodermic needles. However, a 2012 Consumer Reports investigation found that 510(K) clearances often involve high-risk devices, including metal-on-metal hips, transvaginal mesh, and other products that have been linked to serious patient injuries. The article also noted that the vast majority of device recalls announced in recent years involved products that had been cleared via the 510(k) program.
The Institute of Medicine, an organization that provides medical advice to policy makers and the public, has called for an end to the 510(K) program, characterizing it as “fatally flawed.”
The FDA’s proposed guidance recommends that manufacturers seeking 510(k) clearance conduct a risk-based assessment on whether modifications to existing devices could impact their safety and effectiveness. The guidance also clarifies what kinds of device changes would trigger a new 510(K) approval requirement, and it provides some examples of what changes would require a new application and which would not.
“These draft recommendations are intended to help manufacturers determine when a change is significant enough to warrant FDA review, including major changes or modifications to the intended use that could significantly impact safety and effectiveness,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement issued earlier this month. “Medical device technology evolves quickly, and not all changes made to marketed devices alter their safety profile or require our review.
The FDA guidance is non-binding, and the recommendations must still be given final approval before they take effect. The agency is accepting public comments on the matter until November 7th.