The device-specific guidances establish performance criteria to support 510(k) clearance via the new safety and performance based pathways.
The two devices for which guidances have been finalised are cutaneous electrodes for recording purposes and conventional foley catheters. There are four device-specific guidances which still remain in draft for orthopaedic non-spinal metallic bone screws and washers, spinal plating systems, magnetic resonance (MR) coils and soft hydrophilic daily wear contact lenses.
FDA says the new optional safety and performance based pathway builds on its abbreviated 510(k) program to give device makers the flexibility to use performance criteria and voluntary consensus standards rather than direct comparison testing against a predicate device to support 510(k) clearance.
“If a legally marketed device performs at certain levels relevant to its safety and performance for the same characteristics, FDA could find the new device as safe and effective as the legally marketed device. Instead of reviewing data from direct comparison testing between the two devices, FDA could support a finding of substantial equivalence with data demonstrating the new device meets the level of performance of an appropriate predicate device.”