Split Predicate? Nope, That’s A ‘Reference Device,’ FDA Says
This article was originally published in The Gray Sheet
An upcoming FDA guidance will explain how firms can use additional “reference devices” in 510(k) submissions to help reviewers better understand new technologies, the agency says.
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510(k) clearances are the US market on-ramp for most devices, and proving the device is similar enough to an already-marketed product is the entry toll. But a policy in development at FDA's device center offers an optional approach that avoids predicate comparisons. Center director Jeffrey Shuren says in an interview that he expects the new approach will become the "pathway of choice" for many companies, potentially upending what has been a defining characteristic of the device regulatory landscape for decades.
FDA has finalized an important guidance on 510(k) substantial equivalence, but decided to hold off on including sections that would overwrite the popular 1998 “The New 510(k) Paradigm” guidance that describe the abridged special and abbreviated 510(k) routes. Industry strongly objected to FDA’s proposed changes to the special 510(k) program in the 2011 draft 510(k) guidance.
New concepts such as “primary predicates” and “reference devices” may be more confusing than clarifying, former FDA staffers say.