The FDA has announced it will tailor it’s policy toward regulating medical apps in it’s “final guidance” for app developers.

The agency will not enforce medical device requirements detailed in the Federal Drug & Cosmetic Act for the majority of mobile apps, opting to apply regulatory standards only to those apps designed to transform a smartphone or tablet into a regulated medical device or as an accessory to one.

“Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly,” Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a press release. “The FDA’s tailored policy protects patients while encouraging innovation.”

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Medical apps have the potential to transform healthcare — enabling clinicians to diagnose patients with potentially life-threatening conditions outside of traditional health care settings, helping consumers manage their own health and wellness, and providing access to useful information whenever and wherever patients and providers need it.

Those currently on the market perform a variety of functions, ranging from transforming smartphones into ultrasound devices to functioning as the “central command” in glucose meters for those with insulin-dependent diabetes.
Specifically, the FDA will focus regulatory oversight on medical apps that: 
  • are intended to be used as an accessory to a regulated medical device – for example, apps that use picture archiving and communication system (PACS) to enable healthcare providers to make a specific diagnosis
  • transform a mobile platform into a regulated medical device – for example, an app that turns a smartphone into an ECG machine to detect abnormal heart rhythms or heart attack
The agency does not regulate the sale or general consumer use of smartphones or tablets, nor does it regulate mobile app distributors such as the ‘iTunes App store” or the “Google Play store.”
The FDA received more than 130 comments on the draft guidance issued in July 2011. Respondents overwhelmingly supported the FDA’s tailored, risk-based approach.
The agency has cleared about 100 mobile medical applications in the past decade, about 40 of which received approval in the past two years.