FDA: 510(k) Pathway Study 2022

FDA:510(k) Pathway Study 2022 Webinar

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.

Land of De Novo

Traveling to the Land of De Novo

In this webinar De Novo expert Kathy Herzog will take you on a journey entitled Traveling to the Land of De Novo.

  1. What is a De Novo?
  2. When Should I Consider a De Novo?
  3. What are the Timelines and Cost for a De Novo?
  4. How do I Prepare a De Novo?
  5. What Should I Expect with the Review Process?
  6. What are The Business Implications of a De Novo?
  7. Tips for Success