When a 510(k) or PMA Goes Off Track – FDA’s Appeals Process

June 14, 2011

The ability to successfully obtain FDA approval is critical to the success of a medical device.  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?

Hyman, Phelps & McNamara, P.C.'s Jeffrey K. Shapiro is presenting in a June 21, 2011 audio conference on the appeals processes available for medical device companies when FDA takes an adverse action during premarket review of a 510(k) or PMA.  He will discuss practical tips and advice on how to resolve a dispute with FDA so that a 510(k) or PMA can move forward.

Details about the audio conference are available here.  Sign up now!

Categories: Medical Devices