Almost a year after creating a new Safety and Performance Based Pathway for 510(k) eligible products, the US Food and Drug Administration has finalized the first guidances for acceptable performance criteria, covering Foley catheters and cutaneous electrodes.
Last year, the FDA finalized a guidance that expanded its abbreviated 510(k) program that allowed some medical devices to be cleared by the agency if they met certain pre-determined performance criteria. At the time, regulators also published complementary draft guidances for devices including Foley catheters, cutaneous electrodes for recording purposes, spinal plating systems, and orthopedic non-spinal metallic bone screws and washers
