FDA Takes Steps to Modernize 510(k) Program

In a statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., director of the center for devices and radiological health, an update on the 510(k) program was addressed.

“Forty-two years ago, Congress passed the law establishing the framework for evaluating the safety and effectiveness of medical devices. Today, we’re announcing changes to modernize the FDA’s 510(k) clearance pathway, which accounts for the majority of devices that the FDA reviews,” according to the statement. “We’re pursuing these changes to help keep pace with the increasing complexity of rapidly evolving technology. The new technology that we’re seeing holds tremendous public health promise for patients. But with the advances also come new complexities that can make the review of safety and effectiveness more challenging. The framework we propose is aimed at efficiently advancing beneficial technology to patients, while solidifying FDA’s gold standard for safety.”

“We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria,” the statement continues. “We want to make sure that new devices are evaluated against advances in technology that can improve patient safety and performance. In making these reviews, where appropriate, we want to rely on modern safety and performance criteria. At the same time, we’re going to pursue additional actions that will allow the FDA to retire outdated predicates, especially in cases where we’ve seen safer or more effective technology emerge.”

To read the complete statement click here.