Over 250 Medical Technology Executives, Regulatory Affairs, and Industry Consultants responded to the 2022 FDA 510(k) Pathway Survey. We hosted a webinar assembling a panel of FDA law and regulatory professionals to review the results of the study. Ten years ago, DuVal & Associates and Introworks sent out an industry survey to obtain feedback and share insights on the medical industry's experience working with FDA on the 510(k) program. A lot has changed since then, and we have done it again. Round two of the survey was completed earlier this year (2022). The survey gave us a chance to solicit input on how the FDA is doing.
In this webinar De Novo expert Kathy Herzog will take you on a journey entitled Traveling to the Land of De Novo.
- What is a De Novo?
- When Should I Consider a De Novo?
- What are the Timelines and Cost for a De Novo?
- How do I Prepare a De Novo?
- What Should I Expect with the Review Process?
- What are The Business Implications of a De Novo?
- Tips for Success