FDA regulation of mobile devices forthcoming

Regulation of medical apps may be closer than we think. Medical device consulting firm Emergo says that Dr. Jeffrey Shuren, the Food and Drug Administration's Center for Devices and Radiological Health director, confirmed at a town hall meeting held March 10 in Irving, Texas that guidance for such technology will be issued sometime in 2011. According to a blog post, software validation will be required, but it is not known if pre-market [510(k)] approval will be required or not. Post

Suggested Articles

The newly launched Center for Connected Health will be largest telehealth hub in the Philadelphia region, according to Penn Medicine.

The FDA commissioner wants to use additional funding under Trump's budget to advance digital health initiatives and integrate real-world data.

The FDA's approval of an app that uses AI to notify specialists of a potential stroke offers new possibilities for triage software that uses CDS.