- FDA took a step forward in the rollout of a premarket review option available under its Abbreviated 510(k) Program that relies on performance criteria to demonstrate safety and effectiveness, releasing a set of final guidance documents outlining requirements specific to three device types.
- Called the Safety and Performance Based Pathway, the program aims to more quickly advance new products in well-established device categories. A developer using the approach to gain 510(k) clearance for a product would need to show its safety and performance characteristics are consistent with FDA's criteria and would not need to provide a direct comparison with a predicate device.
- FDA on Friday identified criteria and testing methodologies for three types of devices: spinal plating systems, orthopaedic non-spinal metallic bone screws and washers, and magnetic resonance receive-only coils.
When FDA's priorities shifted this year to COVID-19 related work such as emergency use authorization reviews, it pushed back the timeline on other agency initiatives, including efforts to streamline the 510(k) marketing authorization pathway to promote faster access to new medical technologies.
Speaking at an online event earlier this month, Jeff Shuren, director of FDA's Center for Devices and Radiological Health, highlighted the Safety and Performance Based Pathway among priorities the agency will look to advance in 2021.
FDA established the framework for the voluntary pathway, which is intended for moderate risk devices, in a final guidance issued in September 2019. The approach recognizes that older predicate devices may not closely reflect the modern technology embedded in new devices.
Under this alternative route to 510(k) clearance, manufacturers can use validated safety and performance metrics, recognized by FDA, to demonstrate their new products' substantial equivalence to devices already on the market.
FDA is now beginning to build out the program with the release of safety and performance criteria for certain device types it has determined to be appropriate for the new pathway. Spinal plating systems are used in fixation procedures to stabilize the spine for fusion. FDA's guidance for the devices specifically covers anterior cervical and anterior/lateral throracolumbar spinal plates.
The guidance for non-spinal bone screws addresses products designed for orthopaedic fracture fixation, osteotomy, or small joint fusion or arthrodesis, plus the washers used with those devices. The magnetic resonance coils that are the subject of the third guidance are used in hydrogen/proton imaging, to produce images of patient anatomy for general diagnostic purposes.
FDA has said it plans more guidance releases that would apply the Safety and Performance Based Pathway to additional types of devices. The agency also said it wants industry participants to suggest device types for consideration for the program.
In August, FDA published final guidance documents containing performance criteria for the first two device types specified under the pathway: cutaneous electrodes, which are non-invasive devices applied to a patient's skin to record physiological signals, and conventional foley catheters, inserted into the bladder to drain the urinary tract.