RAPS Chicago Chapter: Effective Medical Device Presubmission Interactions

When:  Jan 23, 2017 from 5:30 PM to 8:30 PM (ET)

23 January 2017
5:30–8:30 pm CST
AbbVie Inc.
North Chicago, IL

Join your regulatory colleagues from the Chicagoland area for an evening of networking and an interactive presentation on the Medical Device Presubmission process. The program is brought to you by the RAPS Chicago Chapter and is intended to promote knowledge sharing and engagement with other in the local regulatory community.

When your device is cutting edge, it’s usually best to meet with FDA informally before you send in your request for approval, clearance or clinical study. FDA’s presubmission program is in place to address this need. This presentation will review the program and participants will come away better informed about the details of the program and insight into general principles applicable to all sorts of early interactions with regulatory agencies.

Upon the programs conclusion, attendees will:

  • Understand the presubmission program’s purpose and mechanics
  • Understand basic presubmission application contents
  • Understand how to get the most out of a presubmission interaction
  • Learn principles and effective strategies for any informal FDA meeting

A light meal will be provided and participants may claim two RAC recertification credits.