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.

This audio conference covers:

• History of the De Novo program
• Structure and content of De Novo applications
• FDA review of De Novo submissions
• Current challenges of the De Novo program
• FDA’s review and future plans for De Novo route

About the speaker:

Dr. Zvi Ladin, Principal, Boston MedTech Advisors has over 20 years of management experience in the medical industry, government and academia, focusing on clinical applications, regulatory affairs and reimbursement strategies. His experience includes establishing reimbursement and regulatory strategies for therapeutic and diagnostic medical device companies, submission of regulatory applications, including 510(k) and PMAs for products in Class I-III and drug-device combination products.

Dr. Ladin represented companies in negotiations with the FDA, European and Asian regulatory agencies, and served for five years as a science advisor to the Food and Drug Administration. Dr. Ladin, a recipient of the Whitaker Fellowship and International Research Awards, taught mechanical and biomedical engineering at MIT and Boston University.

He received a B.Sc. in Aeronautical Engineering and an M.Sc. in Biomedical Engineering, both from the Technion, Israel Institute of Technology, as well as a Ph.D. in Medical Engineering from MIT-Harvard Medical School / Division of Health Science and Technology.

Who should attend?

• Regulatory Affairs Directors / Managers
• Quality Assurance Directors / Managers
• Clinical Affairs Directors / Managers
• CEOs
• VPs & Executive VPs