mHealth Regulatory Coalition: About Us

mHealth Regulatory Coalition: About Us

Prior to 2013, FDA offered very little guidance on when and how companies involved in mobile health are regulated.

From 2010 to 2015, the mHealth Regulatory Coalition (MRC) and its General Counsel Bradley Merrill Thompson worked with FDA to develop appropriate rules limiting when technology such as cell phones and other communication and IT devices can get swept within the regulated category of medical devices.

In March 2013, Brad testified before Congress on the connection between the mobile app issues and the medical device tax.

As a part of this work, in the summer of 2013, Brad served as cochair of the Regulations Subgroup of the section 618 FDASIA working group. That group of stakeholders met approximately 30 times over the course of the year to make recommendations to FDA, ONC, and FCC on an overarching strategy for regulating health information technology.

In addition to the September 2013 FDA guidance on mobile medical apps, FDA published two additional guidances requested by the MRC.

In January 2015, FDA published a guidance document that defines the difference between a regulated medical device and a wellness product. That same month, FDA also issued a guidance explaining the triggers for making a product an accessory to a medical device. The coalition identified those two topics, together with clarity around mobile medical apps, as key areas where regulatory guidance was needed to help unleash the potential of mobile health.

Position Statements, Comments, and News Archive

We're pleased to share mHealth Regulatory Coalition position statements, comments, and news from the following periods:

MRC Archive 1 of 3 (June 2010 to September 2011)

MRC Archive 2 of 3 (October 2011)

MRC Archive 3 of 3 (January 2012 to July 2014)

Contact Us

For more information, contact Jennifer Broeker at jbroeker@ebglaw.com or (202) 861-4199.

To view or add a comment, sign in

Insights from the community

Others also viewed

Explore topics