Federal medical device regulators finalized a new guidance this week that prohibits manufacturers from using so-called "split predicates" to establish that their new products are effectively the same as devices already on the market.
The decision, which is 2 years in the making, means that device makers can no longer reference separate predicate devices that have different intended uses when attempting to demonstrate "substantial equivalence." Companies must now rely on a single predicate device or devices that have the same intended purpose.
The 510(k) medical device review pathway allows companies to introduce new products with limited FDA oversight by demonstrating that they are "substantially equivalent" to devices that are already on the U.S. market. Equivalence is demonstrated by citing prior products that serve the same purpose or use the same technologies.
"A new device does not need to be identical to the predicate device for it to be found substantially equivalent to the predicate device," the FDA reminded in a new guidance document issued this week. "Given the diversity of technologies evaluated under this review standard, this guidance adopts a flexible approach to determining ‘substantial equivalence’ to accommodate evolving technology while maintaining predictability and consistency to promote confidence among device developers, practitioners, and patients."
The "split predicate" method, although previously rubber-stamped by regulators, has since been deemed "inconsistent with the 510(k) regulatory standard."
"’Split predicate’ refers to a situation in which a manufacturer is attempting to ‘split’ the 510(k) decision making process by demonstrating that a new device has the same intended use as one marketed device while comparing the new device’s technological characteristics with a second marketed device that has a different intended use," the FDA said. "As a general matter, to find a device substantially equivalent, FDA must be able to address Decision Points 1 through 4 in the Flowchart using one predicate device identified by the manufacturer."
Those decision points are as follows:
Decision 1: Is the predicate device legally marketed?
Decision 2: Do the devices have the same intended use?
Decision 3: Do the devices have the same technological characteristics?
Decision 4: Do the different technological characteristics of the devices raise different questions of safety and effectiveness?
There aren’t figures on how often the split-predicate strategy is actually used, but some respondents to the FDA’s original 2011 draft guidance warned that "FDA would be abandoning a long-standing approach if it followed through with the proposal," Law360.com reported.