FDA Issues Final Guidance On Mobile Medical Apps: Black and White, and Gray

As has been heavily reported, the U.S. Food and Drug Administration has issued its final guidance for developers of mobile medical apps, which are software programs that run on mobile communication devices and perform the same functions as traditional medical devices. The guidance outlines the FDA’s approach to mobile apps.

According to the agency’s release, it intends to exercise “enforcement discretion” (meaning it will not enforce requirements under the Federal Drug & Cosmetic Act) for the majority of mobile apps as they pose minimal risk to consumers.

The FDA says it intends to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended.

Even though some guidance is offer (loosely below), does this not create a slippery slope type of situation? The mobile app market is vast and it is ever changing, literally every day there are new advancements. Give then overwhelming changes, why is the government so confident in its assumption that this rule – now set in stone – will remain relevant with the ever present changes facing the mobile tech and app markets?

Clearly, the pithy bullet points below tell us all we need to know, and for app developers, they now have a clear path forward between the black and white, at least until the FDA decides to start seeing gray. But, I digress, back to the press release:  

“Mobile apps have the potential to transform healthcare by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional healthcare settings, help consumers manage their own health and wellness, and also gain access to useful information whenever and wherever they need it,” the release stated.

Mobile medical apps currently on the market can, for example, diagnose abnormal heart rhythms, transform smart phones into a mobile ultrasound device, or function as the “central command” for a glucose meter used by a person with insulin-dependent diabetes.

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

The FDA is focusing its oversight on mobile medical apps that: 

  • are intended to be used as an accessory to a regulated medical device – for example, an application that allows a healthcare professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or
  • transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

Mobile medical apps that undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices.

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.

“We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” said Shuren. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”

The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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