Bradley Merrill Thompson and M. Jason Brooke join in presenting “The mHealth Regulatory Coalition Presents and Reviews Its Final Mobile Medical Apps Guidance Recommendations to FDA,” a Special Session of the 2011 mHealth Summit.
Overview: In July 2010 the mHealth Regulatory Coalition (MRC) was formed in response to the uncertain regulatory environment facing mobile health (mHealth) innovations and adoption. The coalition brought together a wide group of industries and stakeholders that included the wireless telecommunication industry, medical device manufactures, health information technology companies, healthcare delivery groups and various associations with diverse interests.
Since that time the MRC has worked to clearly define the regulatory challenges posed to mobile health technologies, and then to provide and submit its input to FDA for consideration in the final Guidance Document FDA will publish as advice to industry on how the agency will regulate mobile medical health technology.
This session will review the consolidated final version of the guidance document, taking into account the draft guidance document FDA published on this issue in July of 2011. The combined document will be presented by Bradley Merrill Thompson, General Counsel for the MRC.
For more information, visit mHealthSummit.org.