A Review of Upcoming Regulatory Changes Impacting the Medical Device Community

  • On: January 25, 2016 at 3:30PM
  • Category: Conferences

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
Helping clients be appropriately aggressive, yet compliant. TM