There may be some big changes in store for the 510(k) clearance process. In a meeting last week, FDA staffers questioned whether they need to restrict the accelerated process in order to ensure device safety. The question comes after notable safety issues with contact lenses, heart defibrillators and other devices raised concern that the current process is not rigorous enough.
Under the current system, a device can receive 510(k) clearance if it's substantially equivalent to a device that's already approved. That saves device makers time and money, since they don't have to go through the much more demanding approval process that Class III devices require to reach the market. But the FDA fears that the speedier 510(k) process is being abused, and the agency may ask Congress for more power over Class II devices in order to ensure safety. Currently, the FDA has limited recall powers over marketed devices, as well as how those devices are labeled.
"Developing clear definitions, guidance and additional authorities may be required," said Heather Rosecrans, who heads up the office that oversees 510(k) reviews. Specifically, the FDA may look for greater distinction between Class II and Class III devices.
Critics argue that toughening the 510(k) process could quash innovation and knock the U.S. out of its current position as a leader in device technology. "There is fear in the industry that the FDA may be moving in a direction that isn't rational," Jon Kahan, director of the medical device practice at Hogan & Hartson, tells Dow Jones.