mHealth Regulatory Coalition–part 3

Donna Cusano

The third and final portion of the mHealth Regulatory Coalition’s proposed guidance to FDA–this one on software-specific issues in mHealth software and regulatory approaches–is available on their website (PDF). Included is a fairly deep dive listing of types of software the Coalition recommends be regulated–and not, along with risk assessments and specific levels of regulation. Earlier sections: Part 2 on accessories, Part 1 on intended use claims. On 27 July, the Coalition–in conjunction with the ATA and the Continua Alliance–will host a public meeting at the Westin Hotel in Washington DC to solicit further input. Not yet on website though–stay tuned.