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Nudging Firms To Ditch Older Predicates: A Step In US FDA's Planned 510(k) Reforms

 
• By Elizabeth Orr and David Filmore

FDA says it might start publicizing which marketed devices were cleared based on a predicate at least 10 years old. This "market-based approach" is intended to induce companies to modernize their devices, while the agency also pursues other reforms that might require congressional approval.

FDA entrance sign 2016

US FDA wants to reduce medtech firms' reliance on older predicate devices to support 510(k)s and, ultimately, reduce reliance on any predicates at all.

The agency floated proposals Nov

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More from Policy & Regulation

FDA Announces Classifications On 8 Device Types

 
• By Elizabeth Orr

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