On July 19, 2011, the U.S. Food and Drug Administration (FDA) issued a guidance regarding the agency's plans to regulate select software applications intended for use on mobile platforms (mobile applications or "mobile apps"). According to the Washington Post, the FDA proposed to regulate only those mobile apps which: (1) act as an accessory to a regulated medical device; (2) turn a mobile device or gadget into a regulated device; and/or (3) make suggestions regarding a patient's diagnosis or treatment. Via the Post:
For example, an app that allows radiologists to view X-rays on an iPad or that turns an Android phone into a heart monitor would be regulated. But an app that stores medical records or provides training videos to physicians would not.
'We wanted to make sure that we are consistent in regulating medical devices so nothing has changed,' [FDA policy adviser Baku] Patel said. If 'somebody makes a stethoscope on an iPhone, it doesn’t change the level of oversight we have of a stethoscope.'
FDA's guidance does not establish any legally enforceable responsibilities, but describes FDA's current thinking on this topic and should be viewed only as recommendations. The agency will collect input from manufacturers and healthcare providers over the next 90 days.
You can view the full guidance by clicking here.