FDA guidance exempts most pharma apps from scrutiny
The agency signaled that it will prioritize concern for the functionality of such devices – for example, whether a mobile device's screen size and lower contrast ratio might compromise a radiological imaging app – and safeguarding patient information. And it laid out specific definitions, along with examples, of what it considers to be a “mobile platform,” a “mobile application” and a “mobile medical app,” which “is used as an accessory to a regulated medical device; or transforms a mobile platform into a regulated medical device.”
For pharmas and their agencies, it's what the agency isn't interested in that's more significant. Exempted from the draft guidance were mobile apps that are digital versions of medical textbooks or reference materials but do not contain patient-specific info; tracking logs, appointment reminders and calorie counters; apps that perform medical office functions, such as determining billing codes or handling accounting functions; and those that “perform the functionality of an electronic health record system or personal health record system.”
"The use of mobile medical apps on smart phones and tablets is revolutionizing healthcare delivery," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health, in a statement. "Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don't work as intended."
Digital health shops were pleased with the guidance.
“We're at a significant innovation moment, where the world is changing very quickly” said Havas Worldwide Health digital chief Larry Mickelberg. “The FDA is stratifying oversight into those places that present greatest risk when they don't work. As the technology matures, I'm sure they'll be back with deeper guidance, but as a first step, this is exactly what I would have hoped for.”
The draft guidance places most of what pharmas are working on outside the bounds of regulatory oversight, says Mickelberg, but companies should use it as a reference point in developing processes and procedures with an eye towards the day when patient-specific data is routinely transmitted, “because that's the future, when mobile becomes part of the slipstream.”
Bruce Grant, SVP, strategic services at Digitas, said that many of the developers of those apps that do fall under the scope of FDA's regulatory authority are naive about regulations.
“The mobile health sphere is just now discovering that there are issues involved in doing this,” said Grant. However, for those drug companies that do develop regulated apps, the learning curve will be hardly less steep, since the body of rules governing devices is a whole different animal than those for pharmaceuticals and biologics.
“It's clear they're not looking to empire build,” said Grant. “This is not a land grab. The spirit behind it is one of reasonable interpretation of where their statutory authority begins and ends.”
"Added clarity around this issue is welcome, and I think that in many respects, this guidance seems rational," said Marc Monseau of MDM Communication. "As more people turn to apps on their mobile devices when making decisions about their health, the more important role that the device or app will play, the more important it is that the app is held to certain standards to help ensure performance. However, I do wonder if some elements of what is proposed could add hurdles and slow the development of useful apps that could provide patients with great new ways to manage their conditions -- particularly where an app is simply taking data from an existing, approved device, such as a glucose meter." Monseau also praised FDA for its use of Twitter in answering questions about the draft guidance, saying "It sends a good message."
A public comment period on the draft guidance is open for 90 days, after which the agency will update the guidance based on feedback.