Skip to main content
RAPS Euro Convergence 2023 Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Back
ViewAttendees 12

Sponsor Presentation

Sponsored Presentation: Cybersecurity - New FDA Requirements for Market Applications Effective Now!

Thursday, May 11, 2023
13:00 – 13:30 CEST
Location: Carmine & Charcoal

Sponsored By 
Description:
With new legislative authority in the area of cybersecurity, FDA issued guidance in March defining “cyber devices” and outlining mandatory data for market applications. FDA has given industry six months to transition and ensure such data is available within FDA submissions. Starting October 1st if “cyber device” applications do not contain the required data and information, applicants with received a Refuse To File (RTF) Letter kicking the application out of the queue. Are you ready for these new tougher submission requirements? Do you know how the FDA requirements align or not with the EU policies?

Learning Objectives:

  • Learn about FDA’s new RTF policy and guidance document.
  • Understand the potential testing needed for such data submissions.
  • Discuss how FDA’s new “cyber device” and submission requests do or do not align with the EU regulatory thinking.