FDA Weighs in On Mobile Medical Apps
After years of deliberation, the U.S. Food and Drug Administration (FDA) has issued final guidance on the regulation of smartphone medical devices. In a nutshell, generally speaking any device used in diagnosis or treatment can’t be marketed until it’s approved by the FDA; other apps—such as calorie counters, or pedometers built into a phone—don’t need the FDA’s nod. The FDA’s criteria is how much risk an app poses for a consumer. The agency 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.”
Specifically, the FDA 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.
- 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 whether a patient is experiencing a heart attack.
“We have worked hard to strike the right balance, reviewing only the mobile apps that has the potential to harm consumers if they do not function properly,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”
While the final guidelines were only just released, FDA has cleared 100 mobile medical apps for marketing in the last few years, and 40 of those were just in the last two years.
Synim Rivers, an FDA spokesman, answered questions for NewPublicHealth about the final guidance on mobile medical apps.
NewPublicHealth: What is FDA's concern when it comes to mobile medical apps that led to the recently released guidance?
Food and Drug Administration: There are many advantages to mobile medical applications, and they can contribute to healthier lifestyles and better medical care. But, as with any medical device, they carry a certain amount of risk, and FDA’s job is to assure the safety and effectiveness of medical devices. The FDA believes consumers and health care providers should expect the same level of assurance of safety and efficacy in devices designed to work on a mobile platform as they do from other types of medical devices.
The FDA has adopted a tailored policy for mobile medical apps that protects public health while promoting innovation. The agency is focusing its oversight on a subset of mobile medical apps that pose a greater risk to patients. For mobile medical apps that undergo FDA review, we will apply the same regulatory standards and risk-based approach the agency uses to assure safety and effectiveness for other medical devices.
NPH: What changes did FDA make to the final guidance document in response to comments you received on the draft guidance released a few months ago.
FDA: FDA carefully reviewed more than 130 stakeholder comments on the draft. One key change from the earlier draft is that in response to comments, the final guidance includes more examples [of the types of devices the FDA will regulate].
NPH: How will FDA keep up with emerging apps?
FDA: The FDA works with industry all the time as medical devices technology develops. [And] our oversight of mobile medical apps is based on functionality, not platform.
NPH: What's the best advice for consumers when it comes to considering mobile medical apps?
FDA: Consumers should consult with their healthcare provider before making any treatment decisions. If a consumer experiences any problems with a mobile medical app, they should report them to MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program.
>>Bonus Link: The FDA regularly updates its Mobile Medical Applications Web Page.