In connection with this year's ILSI-Biomed Israel 2011, 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 lawyers will be happy to discuss how Hogan Lovells assists Israeli device companies and answer, as time allows, questions regarding the changing FDA device regulatory environment.
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) and the FDA requirements for clinical support for clearances and approvals of certain devices
The 510(k) notice and the FDA "reform" of the premarket clearance process
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.