FDA's 510(k) De Novo Process - Overview and Current Challenges

is being presented by Dr. Zvi Ladin, Principal, with Boston MedTech Advisors and airs on Thursday, April 28th, 2011. For more details, or to register please visit our site at www.fxconferences.com

Following the enactment of the FDA Modernization Act of 1997, FDA established a new regulatory route for medical devices that present a lower level of risk than Class III and do not have a predicate. ‘De Novo’ applications involve two phases – an initial standard 510(k) process, followed by a review of the risk level of the technology – the De Novo review. The agency committed to completing the second phase within 60 days.

However, things haven't exactly gone according to plan. Until 2007 the average duration of the De Novo review phase was 62 days, with an overall review duration of 245 days. Since 2007 those timelines have stretched to 240 and 482 days respectively – significantly longer than the review of most panel-track, PMA devices.

This audio conference presentation looks at the past, present and future of the De Novo program, how it works, why it hasn't worked as well as expected, and FDA's commitment to review, restructure and streamline the program.