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5 Figures On 510(k) Exemptions: What's The Impact Of US FDA's Recent Actions?

 
• By David Filmore and Melissa Walker

The 21st Century Cures act requires FDA to identify devices to exempt from 510(k) review, a mandate the agency fulfilled earlier this year. But what will be the tangible impact of the hundreds of new device codes removed from 510(k) requirements? This graphical analysis, conducted in collaboration with regulatory intelligence specialist Graematter, shows the effect may not be as large as the top-line numbers suggest. But select specialties and companies may see a few meaningful burdens lifted.

510(k)s exempted codes

US FDA's recent congressionally directed actions to exempt reams of devices from 510(k) requirements may have less of an impact on industry and agency workloads than the top-line numbers suggest, according to an analysis performed by Medtech Insight in collaboration with regulatory intelligence firm Graematter Inc. But there are pockets of companies and clinical specialties where the effects might be more pronounced, the analysis found.

In July, FDA issued a Federal Register notice listing several hundred class II devices that it was exempting...

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