Mobile Applications – Eisner Safety Consultants

Proposal for FDA Create New Office to Regulate Mobile Apps

leoeisner — Thu, 21 Feb 2013 06:59:21 +0000

11 Feb 2013 – Regulatory Focus (RAPS) News Article indicates that there will be a re-introduced proposal going thru the US Congress, sometime this year, for the FDA’s CDRH to create a new office to Regulate Mobile Medical Device Applications. What do you think this will do for the Medical Mobile Apps industry?

Boston Scientific CRV Launches iPad App CardioTeach™

leoeisner — Fri, 11 Nov 2011 07:29:45 +0000

From MedicalDeviceSummit on Nov 10, 2011 – ‘The new iPad app CardioTeach has been touted as industry’s first at helping doctors communicate heart disease and treatment options to patients.’

There is a video demonstration of the CardioTeach iPad app

Apple AppStore iPad link for the CardioTeach

FDA Issues Draft Guidance doc on Mobile “App’s”

leoeisner — Wed, 03 Aug 2011 23:51:38 +0000

On July 21, 2011 the FDA released a draft Guidance document on Mobile “App’s”. There is a 90 day period to submit comments for consideration. (See details on web link for draft guidance).

The draft guidance document states in section IV: “This guidance explains FDA intentions to apply its regulatory requirements to a subset of mobile apps. This subset, which we are calling mobile medical apps as defined in section III (definitions), includes only those that meet the statutory definition of a device; and either:

are used as an accessory to a regulated medical device;
or transform a mobile platform into a regulated medical device.

This guidance does not specifically address wireless safety considerations, classification and submission requirements related to clinical decision support software, or the application of quality systems to software. The FDA intends to address these topics through separate guidance(s).”

Also, the draft guidance details a long list of app’s that don’t fall under this draft guidance document.