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?

Under statutory amendments enacted last summer, FDA now has a statutory requirement to provide applicants with a documented scientific and regulatory rationale for significant decisions, including significant controversies and their resolution by the decision makers. Furthermore, if there is an appeal, FDA has short statutory deadlines to decide an appeal. These provisions could be helpful for those who take advantage of them.

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. With FDA's publication of a draft appeals guidance and a new statutory provision imposing timelines on FDA, an appeal may become a more attractive option than in the past. This 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.

This audio conference covers:

• The impact of the new statutory timing requirements and FDA's draft appeals guidance
• 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
• How to assess the odds of success

About the speaker:

Jeffrey K. Shapiro is a director in the law firm of Hyman, Phelps & McNamara, PC. He has represented medical device companies on FDA-related matters since 1994. He advises on a wide variety of issues in the areas of medical devices, combination products, and human tissue products, including product clearances and approvals, marketing, clinical studies, jurisdictional issues, and enforcement.

Who should attend?

• Directors/VPs Regulatory Affairs
• Directors/VPs Clinical Affairs
• Legal Counsel