212.7K views | +0 today

FDA scrutinises health app for the first time

From www.mobileworldlive.com

The US Food and Drug Administration (FDA) has for the first time written to a company because it needs regulatory clearance for a mobile health app. The FDA has been in touch with Biosense Technolo...
Sam Stern's curator insight, May 29, 2013 12:19 PM

More of things to come?

eMedToday's curator insight, May 29, 2013 7:27 PM

As you develop apps you need to review quidelines for FDA approval. This is a big deal so developers need to be careful

FDA Device Surveillance to Tap App

From online.wsj.com

The FDA is creating a largely automated surveillance system to monitor safety of high-risk medical devices, and has authorized a cellphone app for doctors to simplify reporting deaths and injuries to the agency.
Seth Bilazarian, MD's curator insight, April 24, 2013 4:25 PM

"There's an app for that."  Physicians are often criticized for not doing a better job reporting adverse events and this is largely because the method for reporting to the FDA has been burdensome and difficult. An easy to use reporting strategy from a smartphone will increase my reporting dramatically.  The speed of reporting and analysis by FDA for actionable items should be significantly shortened.

Seth Bilazarian, MD's comment, April 24, 2013 4:27 PM
#app, medical app, #chealth, #mHealth, FDA, adverse event reporting, Bilazarian

How FDA and FTC co-regulate health apps - mobihealthnews

From mobihealthnews.com

mobihealthnewsHow FDA and FTC co-regulate health appsmobihealthnews“We have a similar charge on our end which goes back to 'misbranding' of medical devices.” Patel said that the FTC takes action when there is no “direct harm” posed by the medical...
No comment yet.