Various tracks are coming together in 2011 which will affect the manner in which 510(k)s and other submissions will be reviewed by FDA. The Institute of Medicine report has been peer-reviewed and is expected to be released shortly. However, the FDA list of intended changes contains several items that are about to change, regardless of IOM recommendation.

For medical device manufacturers, it is a time of expectation and, perhaps, a little trepidation. This audio conference takes a look at what is likely to change, and discusses how best to prepare for this new reality.

This audio conference covers:

• Understanding the IOM situation
• How FDA has changed the review process, apart from all the proposed changes
• The schedule of FDA changes and how it interacts with the IOM report
• Interaction of the User Fee reauthorization process with the FDA changes
• The relative importance of safety and effectiveness in the new FDA world

About the speaker:

Robert J. Klepinski is an Officer with Fredrikson & Byron and practices in the Food and Drug Administration, Health Care Fraud & Compliance and Intellectual Property service areas. He is also recognized as one of the leading FDA compliance attorneys. He counsels pharmaceutical, medical device, biotech, food and nutritional supplement companies on FDA policy. Previously, he served as a regulatory attorney for Medtronic. While there, he set the legal strategy for FDA compliance, including advertising and promotion, quality systems, regulatory and clinical.

Robert frequently speaks at local and national trade associations on FDA policy. He has been an adjunct professor at the University of Minnesota Law School and a guest lecturer at other law schools, including Northwestern University, Hamline University and William Mitchell College of Law. He is an adjunct professor at St. Thomas University Graduate School of Engineering and its MBA program.

Who should attend?

• Regulatory Affairs
• Legal Counsel
• Marketing
• Investors
• Senior Management