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.
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US Sen. Bill Cassidy says he wants more details about the FDA’s plans to regulate AI/ML medical software, including a time frame for publishing guidance documents.
Shuren: FDA Making ‘Pre-Cert Simulator’ To ‘Test Drive’ Regulatory Frameworks For Digital Health Tech
US FDA device center director Jeff Shuren said on 6 October that the agency is developing a “precertification simulator” that will allow it to assess different regulatory frameworks in the digital health space.
The largest medical device lobby group will host its annual conference online instead of in person. The meeting that had been set to occur over three days in Toronto will now take place in September and end in October.