Join Dr. Jessica Zdinak on APRIL 9-10 in DC for a 2-day course -- INTRODUCTION TO MEDICAL DEVICE LAW & REGULATION hosted by Food and Drug Law Institute (FDLI).
AGENDA HIGHLIGHTS
Overview of the organizational structure of the FDA
FDA’s regulatory process for medical devices
How to prepare a successful 510(k) submission
Registration and listing requirements
Elements of conducting clinical investigations
Premarket Approval Application (PMA) and approval process
Post-marketing requirements
FDA’s enforcement tools and procedures
Advertising and promotion requirements
Quality System Regulation (QSR)
REGISTER HERE:
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