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.
"While FDA may be taking a more conservative approach than they had in the past by not allowing multiple predicates, the multiple predicate method of claiming ‘substantial equivalence’ has always seemed to me fraught with potential derailment in pursuit of a SE decision, and may have led to some of industry’s perceptions about inconsistency and lack of transparency in their review process," Norwich Clinical Research Associates vice president Glenda Guest commented. "I also believe it complicates the SE process and perhaps contributed to lengthier review cycles. This seems more clear cut and efficient and … objective."
A handful of other forum participants offered similarly positive reviews, adding that the change better aligns the 510(k) pathway with larger FDA goals.
Other commenters chided the new guidance, warning that the change could unfairly limit small companies and those with breakthrough devices that aren’t easily compared to existing technologies.
"This will complicate the process for many device developers, particularly those creating cutting edge devices that are outside the PMA world," consultant Richard Oberreiter remarks. "We would be better off adopting a CE process."
Some chimed in with a more moderate approach, praising the spirit of the guidance but worrying what the change may mean for smaller device makers.
"This is a direction that makes perfect sense. The FDA has made some blunders in the past but this is one that is certainly reasonable. I agree with this direction," MedOneGlobal consultant Bryan Gerzenyi wrote. "However, from a "small company" perspective, especially a start up company with limited funding, it will have an impact. Larger, more well funded companies can certainly afford the time and expense but smaller manufacturers are already feeling financial pain."
