When a 510(k) or PMA Goes Off Track - FDA's Appeals Process

is being presented by Jeffrey K. Shapiro, JD, Director, with Hyman, Phelps & McNamara, PC and airs on Tuesday, June 21st, 2011. For more details, or to register please visit our site at www.fxconferences.com

It goes without saying that the ability to successfully obtain FDA approval is critical to the success of a medical device and, by extension, a medical device company. However, sometimes even the most dedicated of 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?

This presentation covers 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. Our speaker draws upon years of experience to provide practical tips and advice on how to resolve a dispute with FDA so that your 510(k) or PMA can move forward to clearance or approval. The presentation looks at the best approach to take, and what to expect in terms of the length of the appeals process, and the likelihood of success.