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US FDA Toying With Idea Of ‘Regulatory Legos’ In MDUFA V

Executive Summary

Noting the latest round of user-fee negotiations are coming up, FDA device center head Jeff Shuren recently floated the idea of developing statutory building blocks – or what he calls ‘regulatory Legos’ – that would allow the agency to keep up with rapidly advancing medtech products. Instead of constantly asking Congress for new statutory authorities as technology advances, he said, the FDA could have broader authority to bring new products not covered under its current authority to market.

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