FDA Issues Final Guidelines for Mobile Medical Apps

September 24, 2013

FDA issues long-awaited guidance on the regulation of mobile medical apps. Radiology apps to be among most regulated.

The FDA’s long-awaited final guidance for mobile medical applications (apps) was handed down yesterday. And radiology apps were high on the list for regulation.

Looking at the function of the apps rather than the platform, the FDA will focus on apps intended to be used “as an accessory to a regulated medical device,” such as accessing a PACS server on a tablet to make a specific diagnosis. They’ll also regulate apps that transform a mobile platform into a regulated medical device, such as an app that helps a device function as an electrocardiography (ECG) machine, helping to diagnose heart attacks or abnormal heart rhythms.

Mobile apps are software programs run on mobile devices, including smart phones and tablets, that act as a traditional medical device in a different format.

The draft guidance, issued by the FDA in July 2011, was criticized for being too vague. Some app developers complained that without final FDA guidelines, innovation was being stifled, since the pending regulatory decisions could affect their product.

“When the interim regulations came out over two years ago, there was a lot of pushback for the FDA to get a better handle on the criteria by which it would require these apps to be enforced under the FDA regulatory oversight system. There wasn’t a lot of clarity. Now there is,” said Lisa Clark, a law partner with Duane Morris LLP in Philadelphia.

The FDA will look at the app functionality, the health and safety risk to the patient, and will consider developer’s stated use for the app, she said.

The FDA said in its guidelines that the majority of mobile medical apps either aren’t considered medical devices or do meet the definition but are a low health risk to the public. So, the agency will “exercise enforcement discretion” rather than require strict regulation.

Radiology apps were among those that will be most heavily regulated. The FDA said that apps intended only to display or store medical data, but not control or alter it, would fall under a class I requirement, with no monitoring. However, those apps displaying radiology images for diagnosis, changes the platform into a class II PACS system, which increases the regulation.

The FDA final guidelines give this example: “the interpretation of radiological images on a mobile device could be adversely affected by the smaller screen size, lower contrast ratio, and uncontrolled ambient light of the mobile platform. FDA intends to take these risks into account in assessing the appropriate regulatory oversight for these products.” PACS server images fall into the category of patient-specific medical device data because it meets the definition of a medical device data system (MDDS) to perform active patient monitoring.

Two additional radiology functions were also listed. Computer aided detection (CAD) software will be considered highly regulated because the software performs sophisticated analysis or interprets data. Mobile apps that connect to another device to control its operation, function or energy source are also in the strictest category, including apps that act as wireless remotes to control or sync CT or X-ray machines.

The apps the FDA is most concerned about are ones that will pose a greater health risk to patients if they don’t work as intended.

“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, MD, JD, in the FDA’s press release. Shuren is the director of the FDA’s Center for Devices and Radiological Health.

The FDA created three classes of mobile app for regulatory purposes, Clark said. Class I is the least onerous with no 510(k) premarket notification required. These apps are not considered medical devices and are thought to have a low level of patient safety risk as they are used generally for informational purposes. Class II apps may be considered medical devices, requiring the developer to submit a 510(k) premarket notification before marketing the app. The FDA will not focus on these apps, but will use its enforcement discretion if a problem arises. Class III apps require a full FDA review and approval before putting the app on the market and will fall under the same regulatory standards as traditional medical devices.

What’s interesting in this case, Clark said, is that the FDA is requiring all mobile medical app manufacturers to comply with quality systems (QS) regulations. This requires building good manufacturing practices into the app from the start.

“That seems to be where lot of other agencies are going, in terms of compliance obligations on mobile apps,” she said.

While it’s not quite self-policing, Clark said the FDA wants app manufacturers to develop the apps properly on the front end, validating them, and making them secure and safe. If the app has problems later and can show that QS regulations were met, the FDA would take that into consideration.

The FDA final guidelines include a long list of app types and class determination. They also differentiate between apps made or altered to use privately (even sharing them with others in the practice), versus those apps that are distributed with the intention of making them generally available to health care practitioners. Any developers unsure of where their app fits in should contact the FDA for additional guidance.

As for how many apps will be affected, no one knows. The FDA said in its press release that it has cleared roughly 100 medical mobile apps in the past 10 years, 40 of those in the last two years alone. The healthcare app market is expected to grow by 25 percent annually through 2016, according to a 2012 Kalorama Information report.

It is possible, Clark said, that the FDA, in the wake of its new guidance, could see significant activity from app developers and investors who had been waiting on the agency to speak on the subject.

But that doesn’t mean the agency will hear from every developer.

“Those who were more sophisticated had gone to the FDA anyway,” she said.

Full FDA guidance can be found here