Examining the Implementation of the 21 Century Cures Act and the Effects for Medical Devices

July 27, 2017 1:45pm

Paulette M. Mara
Michael Best & Friedrich LLP (Washington, DC)

  • Expedited Review Process for Breakthrough Devices
    • Broadening the use of expedited review to include 510(k) and de novo pathways
  • Expanding the use of the Humanitarian Device Exception (“HDE”)
  • Clarifying Medical Software Regulation
    • Reviewing the classes of software excluded from device classification
    Identifying software functions that are “reasonably likely to have serious adverse health consequences”