Formation of mHealth Regulatory Coalition

The mHealth Regulatory Coalition (MRC) is a new and significant coming together of organisations with an interest in influencing how mobile health applications or software are classified in the USA as medical devices by the FDA, MDD or other regulatory agencies. Its stated purpose is to be temporary (as in months – first meeting on July 8 in Washington, including remote participants) and to create a guidance document to be submitted to the United States FDA clarifying the mHealth hardware and software issues that the agency plans to regulate/not regulate. (Regulation in the US will, of course, have an effect worldwide.) At the moment you can only find details on LinkedIn – here is the founding statement, and here is the (fascinating) discussion that led up to it: Are mobile health applications or software classified as a Medical device by FDA/MDD or by any other regulatories? If any reader needs an invitation to join the Wireless Health group in order to read these items, email editor Steve.

UPDATE 12 June 2010: Latest, final and unmissable article in the FDA regulation series by Bradley Merrill Thompson in MobiHealthNews: The Dynamic Future of FDA Regulation of mHealth (Warning. This article contains explicit and sometimes graphic depictions of possible FDA regulation.)