Events
Duane Morris Special Counsel Michael Swit to Discuss "The Premarket Notification (510(k)) Process"
June 5, 2012 | Palo Alto, California
| Crowne Plaza Cabana Hotel
Duane Morris special counsel Michael Swit will be discussing "The Premarket Notification (510(k)) Process" at the Food and Drug Law Institute's (FDLI) Introduction to Medical Device Law & Regulation Conference on Tuesday, June 5, 2012.
The Introduction to Medical Device Law & Regulation conference is an in-depth, interactive two-day course, featuring an array of industry specialists speaking on a range of relevant topics. Subjects include the FDA's regulatory and organizational structures; legal framework of device regulation; preparing a successful 510(k) submission; and new and developing FDA policies and procedures, to name a few.
The session on "Premarket Notification (510(k))" will provide a closer examination of the 510(k), including its legal basis and content. Mr. Swit will define Substantial Equivalence, and also share some updated information on the 510(k) Working Group, the Institute of Medicine's study, and the possible future of 510(k)s. Finally, there will be an assessment of a 510(k) case study to conclude the session.
For additional information, or to register, please visit the FDLI website.
