FDA Status Update on mHealth, Wellness, and Clinical Decision Support

Webinar (EDT)

Kim Tyrrell-Knott, Member of the Firm, presents "FDA Status Update on mHealth, Wellness, and Clinical Decision Support," a webinar hosted by Regulation Station.

Mobile medical apps have soared in popularity over the past 5 years, and in early 2015, the FDA released two guidance documents illustrating their intent to regulate general wellness devices and mHealth applications. Superseding the 2011 guidelines, the documents outline the FDA’s parameters on which devices will and will not be regulated. While the current guidance is yet to be finalized and stakeholder reactions have been mixed, the device industry actively awaits to see how patients will utilize mHealth devices and if the FDA’s regulation will promote innovation and safety.

  • Risk classification and proposed scope for regulatory oversight
  • Definitions of mobile medical apps and device accessories
  • Implications for various stakeholders and overall health IT
  • Takeaways from Dexcom glucose monitoring app

Participants that will find this webinar most beneficial will be those involved in medical device and diagnostics companies. Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs
  • Regulatory Operations
  • Mobile Device/Product Development

For more information, visit Regulation-Station.com.
Use promotion code of EBGR for $50 off the price of registration.