FDA final mobile medical app guidance mirrors 2011 draft

After a more than two-year wait, the U.S. Food and Drug Administration today issued its final guidance on mobile medical applications, according to an announcement from the regulatory agency. Going forward, the FDA states that it will take a "tailored approach" to mobile medical apps that "supports innovation while protecting consumer safety."

The FDA's final guidance matches the overall direction the agency provided in its July 2011 draft guidance for mobile medical apps--namely, that it will focus on a "small subset" of the app market and only those apps that present the greatest risk to patients. 

"The agency 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," according to the announcement. "The FDA 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."

The FDA indicated that the agency will focus 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 health care 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

According to the agency's announcement, "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." At the same time, the FDA made the point of emphasizing that it "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's much-anticipated final guidance on mobile medical apps couldn't come soon enough for mHealth developers who have strongly urged the agency to finalize its regulations. Over the past year, in particular, the FDA has come under fire from critics, including members of Congress, for being slow to finalize its draft guidance, which critics charged was unclear and unpredictable.

"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," Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement. "Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products."

In an email response to a query from FierceMobileHealthcare, Bradley Merrill Thompson, who serves as general counsel for the mHealth Regulatory Coalition, said the organization is "absolutely delighted that FDA published this guidance" in accordance with the timeframe--by the end of fiscal 2013--promised to Congress.

Nevertheless, Thompson said that while "there is much that is very helpful in this guidance document," and while MRC is "particularly pleased that FDA is looking for innovative ways to communicate on a more ongoing basis the kinds of technologies that are regulated, and the kinds that are not," he is disappointed that "the final guidance is fundamentally like the proposed guidance, and omits some very important areas."

According to Thompson, those omissions in the FDA's final guidance include: the definition of what are regulated; disease intended uses compared to unregulated, wellness intended uses; and the exact meaning of an accessory to a medical device. However, he said it was his understanding that the FDA is "working on those two topics separately so we look forward to seeing what the agency comes up with."

Likewise, a recent FDASIA Workgroup report to ONC's Health Information Technology Policy Committee made recommendations regarding the FDA's regulations. Among the main issues the report said FDA must address in terms of mHealth were defining the levels of risk for mobile devices and their accessories and determining which require regulating and which necessitate enforcement discretion.

"The FDA has a long-standing rule which says that anything intended to be used as an accessory to a medical device is itself a medical device and regulated to the same level as the device it accessorizes," the report stated. "But there are many generic, low-risk accessories that should not take on the regulatory classification of the product it is intended to accessorize."

To learn more:
- read the FDA announcement