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
Boston Scientific CRV Launches iPad App CardioTeach™
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
FDA Issues Draft Guidance doc on Mobile “App’s”
On July 21, 2011 the FDA released a draft Guidance document on Mobile “App’s”.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 (See details on web link for draft guidance). The draft guidance document states in section