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

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.

FDA

As the US Food and Drug Administration begins gearing up for user-fee negotiations with the medtech industry starting next year, the head of the agency's Center for Devices and Radiological Health (CDRH) has floated the idea of developing so-called regulatory building blocks. He says the concept would be to give the FDA broader powers, thereby reducing its need to constantly ask Congress to authorize specific programs that are not explicitly stated under statute.

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