Marketing a medical device in the United States requires complying with myriad Food and Drug Administration (FDA) regulations. Implementing an effective regulatory strategy can be complicated, time consuming and costly – manufacturers need to get it right the first time. For many years, dealing with FDA was fairly predictable. However, these days it is not 'business as usual' at FDA – change is in the air. FDA is under new, ever-changing management and has significantly increased the number of field inspectors. Enforcement actions are on the rise, both domestic and international. FDA has also pledged to “revamp” the 510(k) system. So many changes (and more sure to come) – how do manufacturers deal with the uncertainty?

This audio conference presentation discusses the ongoing changes within FDA, and what that means in terms of enforcement focus. Our speaker reviews the compliance mistakes made most often by device manufacturers, and provides pointers on how best to interact with FDA.

This audio conference covers:

• Insights into what’s going on at FDA today
• Examples of new areas of focus for FDA
• Examples of common mistakes that manufacturers make in trying to be FDA compliant
• Tools to deal with the FDA

About the speaker:

Stephen D. Terman concentrates his practice in medical device law, FDA regulatory issues, and litigation. He has represented over 200 corporations, individuals and associations in civil, criminal and regulatory matters. Mr. Terman's expertise covers all areas of medical device law including the Quality System Regulation, Medical Device Reporting, IDE, 510(k) and PMA submissions. He has helped companies respond to FDA inspectional observations, Warning Letters and recalls, as well as civil penalty actions, injunctions, clinical disqualifications and criminal prosecutions. Mr. Terman has handled countless medical device matters in the last 24 months covering a wide variety of medical devices including but not limited to cardiovascular, orthopedic, etc. He has also helped many inventors and companies bring their innovative co! ncepts to market. Mr. Terman was honored by the Washingtonian Magazine as one of Washington, DC's top FDA lawyers 2007, 2008 and 2010. Mr. Terman was also nominated by his peers as one of the world's leading practitioners in his field, and is listed in the International Who's Who of Life Sciences Lawyers 2008 and 2010.

Who should attend?

• VPs, Regulatory Affairs and Quality
• Directors, RA/QA
• Managers, RA/QA
• Specialists, RA/QA