USA – FDA outlines safety and performance-based criteria for facet screw systems and denture base resins

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Monday issued two draft guidances outlining the performance criteria and testing methodologies device makers can use to support 510(k) submissions for denture-based resins and facet screw systems under the agency’s safety and performance-based pathway.

FDA issued final guidance in September 2019 explaining the new safety and performance-based pathway, which allows device markers to seek 510(k) clearance for certain devices based on performance criteria and voluntary consensus standards rather than direct comparison testing to predicate devices. (RELATED: CDRH takes first step to operationalize new safety and performance based pathwayRegulatory Focus 19 September 2019).

This pathway is only for new devices that have the same indications for use and technological characteristics, and that do not raise different questions of safety and effectiveness than the predicate device…