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US FDA Emphasizes Computer Modeling, Existing Data For Least-Burdensome Device Submissions

 
• By Sue Darcey

FDA explains what qualifies as “the minimum information necessary,” including existing data, peer-reviewed data, and validated computer modeling, for new device and diagnostic applications, in a final “least burdensome” guidance released Feb. 4.

USFDA plans to take both formal and informal approaches to reviewing device applications and is willing to accept existing and post-market data, outside-of-the US data and case histories in reviewing device submissions, it says in a final “least burdensome” guidance.

In the guidance, the agency also asks that industry submit applications to the agency that are well-organized, clear and concise, and reference any applicable FDA guidance document.

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