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