Experts: FDA Needs Authority To Resolve 510(k) Device Pathway Issues

By Lia DeGroot / January 12, 2023 at 11:13 AM
Two recently published research papers show that 510(k) medical devices that were authorized based on recalled predicate devices are more likely themselves to also be recalled, and a pair of Harvard professors say FDA, Congress and device industry stakeholders need to take several actions to remedy the issue. Congress specifically needs to give FDA authority to prohibit 510(k) device sponsors from using recalled medical devices as predicates for clearance, stakeholders need to develop models that can better predict or identify...

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