FDA finalizes two more safety and performance based pathway guidances

Regulatory NewsRegulatory News | 12 April 2022 |  By 

The US Food and Drug Administration (FDA) on Tuesday published two more final safety and performance based pathway guidances for medical devices on the heels of releasing two other guidances under the pathway last week. The newly finalized guidances provide recommendations for device makers to follow the less burdensome pathway for facet screw systems and denture base resins.
In total, FDA has issued nine device-specific safety and performance based pathway guidances since launching the pathway in 2019. (RELATED: CDRH takes first step to operationalize new safety and performance based pathway, Regulatory Focus 19 September 2019; FDA eases review burden for certain sutures, orthopedic devices in leap-frog guidances, Regulatory Focus 11 April 2022)
On 12 April, the agency published guidances that allow certain denture base resins and facet screw systems to use the optional pathway, which allows companies to demonstrate substantial equivalence by meeting established safety and performance criteria, rather than via direct comparison testing.
FDA notes that its Facet Screw Systems – Performance Criteria for Safety and Performance Based Pathway guidance cover devices that use metallic bone screws and optional washer components that are currently unclassified.
“The facet screw systems that fall within the scope of this guidance document are intended for bilateral immobilization of facet joints to stabilize the spine as an aid to fusion,” the agency notes. “The optional washer components are intended for use with the facet screw to aid in load distribution at the screw head/bone interface.”
Similarly, the FDA states that its Denture Base Resins – Performance Criteria for Safety and Performance Based Pathway guidance covers prosthetic devices that use denture rebasing resin composed of materials such as methyl methacrylate and are intended to reline denture surfaces that contact tissue, to repair a fractured denture, or to form a new denture base. The agency also notes that the devices are not for over-the-counter use.
“These devices are intended for the fabrication of patient-specific denture bases for full or partial dentures,” the agency added.
Both guidances list various performance testing criteria that should be met, including mechanical testing and biocompatibility evaluation, while the facet screw systems guidance also lists sterilization and reprocessing validation and the denture base resin guidance includes a section on additive manufacturing, or 3D-printing, considerations.


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