FDA Revamps Medical Device Reviews

FDA released a plan on Jan. 19 to overhaul how the agency approves medical devices under its 510(k) review process. Although the process is intended to determine whether a low-risk device is equivalent to one that is already on the market, FDA has long been criticized for using the 510(k) pathway to approve high-risk medical devices without having sufficient evidence that the products are safe and effective. Industry argues that the 510(k) process is unpredictable and not transparent, and consumers and health care experts say that it isn’t robust enough. FDA plans to implement 25 actions this year to improve the 510(k) process, including streamlining it for low-risk devices, clarifying when clinical data are needed in premarket applications, and establishing a new council of senior FDA staff who will “ensure timely and consistent science-based decision-making.” FDA’s actions will result in “a smarter medical device program that supports innovation, keeps jobs here at home, and brings effective technologies to patients,” Jeffrey Shuren, director of FDA’s Center for Devices & Radiological Health, said in a statement.