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FDA's Alternative 510(k) Proposal Falls Flat With Industry

Executive Summary

The US regulatory agency has touted its newly proposed voluntary "expanded abbreviated" 510(k) program as a modern approach to regulation that will simplify the path for many. But industry groups are mostly scratching their heads.

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Despite pushback from industry, US FDA has moved forward with plans to establish a new alternative 510(k) pathway by finalizing a guidance document that describes the so-called “Safety and Performance Based Pathway” that emphasizes use of consensus standards instead of direct predicate comparisons. 

An FDA Age-Based Predicate Policy Would Be Arbitrary, Reg Experts Complain

The device industry is still sorting out the implications of US FDA's recent proposals to make what the agency describes as a major update to the 510(k) process. But regulatory experts say the agency's focus on finding an age-based cut-off for 510(k) predicate devices is misguided, and some argue that Congress should need to sign off on any of the floated policies.

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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.

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