RAPS: US FDA Pre-Submissions
Venue: Hilton Rotterdam, Weena 10, Rotterdam, Zuid-Holland, Netherlands, 3012 CM
Start: Thursday 29 Feb 2024 09:00
End: Friday 01 Mar 2024 17:00
Compiling regulatory dossiers for device registrations is time-consuming and expensive. With the constant changes in the regulatory landscape, it is good to know the expectations and receive FDA feedback for regulatory strategy including predicate selection, technical or analytical validation and clinical evidence prior to conducting verification, validation, and clinical studied. The U.S. Food and Drug Administration (FDA) offers several mechanisms through which a manufacturer can directly request feedback from the FDA regarding proposed study designs and strategies for medical devices/IVDs as part of their Q-submission program.
This 2-day workshop will review the multiple types of pre-submissions, or Q-submissions, available to manufacturers and how to leverage these to reduce the time and costs to bring medical devices to market in the U.S.