In connection with this year's ILSI-Biomed Israel 2010, Hogan Lovells cordially invites you to join us for lunch and a presentation on the key issues facing the U.S. Food and Drug Administration (FDA) regulation of medical devices. Our Hogan Lovells lawyers will be happy to discuss how the firm assists Israeli device companies and answer, as time allows, questions regarding the changing FDA device regulatory environment.
This session has limited seating and is available only to Medical Device Attendees of ILSI-Biomed Israel 2010.Key Issues to Address
Gaining FDA clearance or approval to market a new medical device in the United States is a complex and increasingly challenging process under the “New FDA”. This presentation reviews the various types of FDA submissions as well as the key strategic aspects of these filings, including:
- The Investigational Device Exemption (IDE)
- The 510(k) notice
- De novo downclassification
- The Premarket Approval (PMA) application
- The Humanitarian Device Exemption (HDE) application
- In addition to the foregoing specific discussions, we will review how to successfully work with the Center for Devices and Radiological Health in this period of rapidly FDA changing policies and approaches. This will include a discussion on how to deal with difficult lead FDA reviewers and the process for appealing adverse decisions during the premarket approval/clearance processes.