mHealth Industry Response To FDA Mobile Medical App Policy Begins To Gel
This article was originally published in The Gray Sheet
Mobile health and telemedicine stakeholders have much to say about FDA's recently released draft guidance for regulating mobile medical apps.
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The medical device and software industries voiced support last week for a July 19 FDA draft guidance that helps clarify the types of mobile software applications that would face FDA regulation.
Advances in cloud computing – where data storage or processing tasks for a software application are distributed among multiple remote computer networks – are adding a new wrinkle to industry’s efforts to draft a mobile health regulatory guidance document for FDA review.
Manufacturers attending a meeting last week on the convergence of wireless communications and medical devices were encouraged by a new agreement between FDA and the Federal Communications Commission to clarify regulations for the burgeoning product category