Events

A Review of Upcoming Regulatory Changes Impacting the Medical Device Community

Monday, January 25, 2016 3:30pm - Monday, January 25, 2016 4:30pm
Category: Conferences
Presenter: Mark DuVal
Organizer: Q1 Productions
Register:

Topics covered:

  • Adhering to FDA's refuse-to-accept policy
  • Expected changes to 510(k) & De Novo approval pathways
  • The future of companion diagnostics & the impact on the medtech landscape
  • Anticipating an update from the agency on MDUFA reauthorization
  • Panel discussion: Collaborating with FDA to ensure Medtech Approval
  • Paving the road for continued innovation: partnering with FDA
  • Utilizing pre-submission meetings to accelerate product approval
  • Recent trends in FDA feedback on product submissions
  • Regulatory compliance despite lack of resources

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