HIGHLIGHTS
SUMMARY
The United_States Food and Drug Administration`s 510(k) process for medical devices is based on "substantial equivalence" to devices cleared pre-1976 or legally marketed thereafter, known as predicate devices. Predicate creep has been identified as one of the causes of some well-known medical device failure, such as the clearance of metal on metal hip implants, surgical meshes, and the ReGen Menaflex collagen scaffold, where what might seem as small differences between a device and its predicate were enlarged over time. Substantial equivalence, however, only supports an assessment that the device introduces . . .
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