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Evaluation ViewAttendees 41

Sponsored Presentation: Crossing the eSTAR Chasm: How to Transition to FDA’s Mandatory 510(k) eSTAR Submission Process

Thursday, October 5, 2023
11:15 AM – 11:40 AM EDT
Location/Room: Exhibit Hall: Ignite! Stage (Booth 623)
This session will educate and prepare medical device manufacturers, regulatory affairs leaders, and regulatory consultants to effectively transition their processes, resources and operations to seamlessly adopt the eSTAR as the new submission standard. This session will share watchouts, best practices, and tips and tricks to adapt to eSTAR.

Learning Objectives:

  • What is eSTAR?
  • How does eSTAR impact regulatory affairs moving forward?
  • What are the main challenges that RA teams must overcome with eSTAR?
  • How to prepare for eSTAR and immediately adapt to the new guidance and requirements