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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. 26 that Commissioner Scott Gottlieb called "the most significant modernization of the 510(k) clearance pathway in a generation." But the proposals in many cases...

Specifically, FDA suggested that it would like manufacturers to take a hard look at predicate devices that are more than a decade old. FDA believes the changes could help ensure...

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• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 
• By Amanda Maxwell

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 
• By Natasha Barrow

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