mHealth Regulatory Coalition releases full draft guidance (US)

Donna Cusano

This is the complete proposed guidance document to the FDA on regulation of mHealth technologies, as drafted by the mHealth Regulatory Coalition (MRC). It incorporates comments from the prior three releases of materials [TA 5 July and prior]. This document is the culmination of over a year’s worth of work from a diverse group of stakeholders in the mHealth industry. After publishing a whitepaper at the end of 2010 on the regulatory challenges, the MRC with this document intends to address these challenges. Comments are open until 12 October and should be directed to Jason Brooke at Epstein, Becker (jbrooke@ebglaw.com). The full 55-page document isn’t available off the home page, but we have the PDF right here. MRC’s Proposed Guidance for Industry and FDA Staff: Regulation of mHealth Technology