A No-Predicate 510(k) Future? Pending US FDA Policy Might Forge A Path

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.