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

Executive Summary

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.

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