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

Our Price: $395.00

Product Code: WB-7133

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About the Product
Includes 1 hour and 10 minute Windows Media Video File and PowerPoint presentations for immediate download.

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

Kim Tyrrell-Knott
Member of the Firm
Epstein Becker Green

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

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