The US Food and Drug Administration (FDA) has announced new steps it is taking to modernize the 510(k) program, which include updates on its Safety and Performance Based Pathway, electronic Submission Template And Resource (eSTAR) program and draft guidances concerning specific components of the 510(k) program.
FDA’s Safety and Performance Based Pathway, launched in September 2019, was designed to allow sponsors with well understood device types to demonstrate safety and efficacy of their devices through FDA-identified performance criteria. The agency noted ten final guidance documents have been released since the final guidance for this pathway was released, and include guidances on spinal plating systems, orthopedic non-spinal metallic bone screws and washers, magnetic resonance receive-only coils, cutaneous electrodes for recording purposes, conventional foley catheters, fracture fixation plates, surgical sutures, denture base resin, facet screw systems and soft (hydrophilic) daily wear contact lenses. More device-specific guidances for the Safety and Performance Based Pathway are on the way, FDA said…
