Final rule prohibits “split predicates” under 510(k) process

July 29, 2014 by Arezu Sarvestani

Medical device regulators clamp down on the 510(k) review pathway, prohibited manufacturers from splitting their primary substantial equivalence claims between multiple devices.

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.



Josh Sandberg

Josh Sandberg is the President of Ortho Sales Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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