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What the 21st Century Cures Act Means for Medtech


Yarmela Pavlovic, Esq. (Partner, Hogan Lovells)

Michael Hoffman (Deputy Director, Division of Neurological and Physical Medicine Devices, FDA)

Shane Pew (Director of Quality Assurance, Myriad Genetics Laboratories Inc.)

Rick White (CEO and Co-Founder, Sure Genomics)

Location: 210D

Date: Wednesday, February 7

Time: 4:00pm - 5:30pm

Pass Type: Conference (Paid) - Get your pass now!

Conference Track: MD&M: Regulatory & Quality Update

Vault Recording: TBD

The 21st Century Cures Act gave FDA new power and resources to accomplish its mission. The act provided FDA with tools aimed at modernizing regulatory programs, with the goal to facilitate access to safe and effective innovation. So, what does this mean for medical device manufacturers?

Topics to be covered include:

  • Update on the FDA’s plans to roll out various components of the program
  • What are the changes and what’s still in the pipeline?
  • Downstream effects on reimbursement related to the coverage, coding, and reimbursement of medical technologies
  • What the 21st Century Cures Act means for manufacturers offering cutting-edge products