• Welcome to this year’s event!
  • Don’t miss the keynote presentation ‘Trends in Mobile Monitoring’ from Dr. Yan Chow

FDA review process: How the FDA makes decisions

10:30 - 11:00

  • Devising the best regulatory strategies for your products in light of MDUFA III
  • An update on 510(k) changes including the new Refuse-To-Accept policy
  • Establishing effective communication channels with FDA staff
  • How to prepare a successful submission

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