New research from the University of Minnesota, published in the Journal of the American Medical Association, challenges conventional wisdom and prompts discussion among medical device manufacturers by raising questions about—and perhaps providing guidance to help avoid—FDA safety recalls for 510(k) devices.
The study, titled “Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance,” sought to answer the question: “Are features of predicate medical devices referenced in 510(k) regulatory submissions associated with product recalls?”
The outcomes may be surprising because they suggest that newer is not necessarily better. They also identify other factors that could determine whether a device ends up in the 11.4 percent of devices that experience at least one class I or class II recall (i.e., recalls with a potential for harm).
Click to read Spotting Problems in 510(k) Submissions to Avoid Device Recalls written by Bowman and Brooke Senior Counsel Joseph Mrkonich and published in the Medical Device and Diagnostic Industry online publication.