The ability to successfully obtain FDA approval is critical to the success of a medical device. However, sometimes even the most dedicated efforts fall flat when FDA says “No.” What then? What can you do if FDA says it believes there is not an adequate predicate device for your product? Or if FDA is requiring an overly burdensome clinical study? Or imposing data requirements that were not applied to your competitor's similar 510(k) six months earlier?
Hyman, Phelps & McNamara, P.C. Director Jeffrey K. Shapiro will be the featured speaker at a webinar scheduled to take place on January 10, 2013 from 11:30AM to 12:30PM (Eastern). The webinar, titled “When a 510(k) or PMA Goes Off Track – FDA’s Appeals Process,” will cover the appeals processes that are available to medical device companies when FDA takes an adverse action during premarket review of a 510(k) or PMA. Specifically, Mr. Shapiro will discuss:
- The appeal procedures available when a dispute arises with FDA;
- How to choose the right procedure and formulate a strategy for resolving the dispute;
- Practical tips on how to resolve the dispute as quickly as possible;
- How long an appeal typically might take;
- The impact of the new statutory timing requirements and FDA's draft appeals guidance; and
- How to assess the odds of success.
You can register for the webinar here. Mr. Shapiro has authored several articles on the medical device appeals process – see here, here, and here – and will be discussing the latest FDA guidance and procedures on the topic.