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

 
• By David Filmore

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.

Business development idea and developing industry success through creative invention as a light bulb evolving to a gear shape as a 3D illustration.

The process of comparing a new device to an already-marketed predicate device to prove substantial equivalence is a core driver of the US device market. It also aligns with the iterative innovation cycle, where products are continually updated to enhance outcomes and usability, that the device industry embraces.

But the reality, both FDA and industry say, is that it is proving increasingly difficult to show substantial equivalence between...

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The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.

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EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 
• By Amanda Maxwell

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

More from Policy & Regulation

Medtech Giants Brace for Tariffs Impact: Responses Range From Financial To Philosophical

 
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More Haste Less Pace? Challenging The ‘Early As Possible’ Principle In Medtech Innovation

 
• By Stuart Grant

The rallying cry to start as early as possible has become increasingly common in the world of medical device development. Innovation expert Dr. Stuart Grant challenges this conventional wisdom, asking: Is "sooner" truly better, or is there a smarter path to market for your medical device?