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.
