August 6, 2014 by Arezu Sarvestani
The FDA’s new guidance against split predicates in medtech 510(k) applications gets a largely warm welcome from industry insiders.
The FDA’s decision to ban so-called “split predicates” in medical device 510(k) applications was met largely with praise from members of the Medical Devices Group on LinkedIn.
A few voices in the crowd expressed concern or ambivalence about the decision, but most commenters agreed that the change “makes sense and seems fair.”
The “split predicate” method, although previously rubber-stamped by regulators, has since been deemed “inconsistent with the 510(k) regulatory standard,” the FDA said. In new guidance, which was 2 years in the making, regulators asked device makers to rely on a single predicate device or devices that have the same intended purpose when establishing substantial equivalence (SE) for a new product.