By Carrie Wells and Toni Clarke, Staff and wire reports
8:04 PM EDT, September 23, 2013
WellDoc Inc., a Baltimore-based company that makes mobile apps to manage chronic disease, welcomed the Food and Drug Administration's announcement Monday of final rules governing the development of mobile medical apps.
"It does put us at ease that we're not going to get a curveball," said Chris Bergstrom, WellDoc's chief strategy and commercial officer. "Removing the uncertainty will allow some dollars to come in and more innovation."
The rules come more than two years after the FDA released draft guidance in which it proposed regulating any mobile app deemed to be a medical device.
The FDA said it will only regulate products that transform smartphones into devices the agency currently regulates, such as electrocardiography (ECG) machines that can determine whether a patient is having a heart attack.
The FDA also said it will regulate apps that would be used as an accessory to a regulated device, such as one that displays images used by physicians to diagnose patients.
The agency said it will not regulate the sale or general consumer use of smartphones or tablets or mobile app distributors such as the iTunes store or Google Play store. Nor will it regulate personal wellness apps such as pedometers or heart-rate monitors.
WellDoc's founders decided early on to seek FDA approval for their products despite the hurdles, because they thought it would be more appealing to consumers, Bergstrom said. The new rules contained "no surprises," he said, and won't affect a new app called BlueStar the company plans to launch soon, designed to help those with Type 2 diabetes manage their illness.
Dr. Jeffrey Shuren, director of the FDA's medical device division, said on a conference call with reporters that whether the agency regulates a product will depend on its function and its risk. If a heart device used in a hospital is currently regulated, chances are a mobile app will be too.
"It's not about the platform. It's about the functionality," Shuren said. "An ECG is an ECG."
Such products will need to be cleared by the FDA before being allowed on the market. The agency has cleared about 100 mobile medical apps over the past decade, of which 40 were cleared in the last two years, including WellDoc's BlueStar. Shuren said the average review time was 67 days.
The agency said it is not going to enforce its powers on mobile apps it considers relatively safe, such as those that help patients organize and track their health information, promote strategies for maintaining a healthy weight, or help patients adhere to medication dosing schedules.
According to a report published in March by research2guidance, a research firm, the market for mobile health apps will reach $26 billion by 2017. Currently, there are about 97,000 mobile health applications in major app stores, the report said.
Obtaining FDA approval for a mobile medical application can be time consuming and costly, said Bergstrom. He cited a 2010 Stanford University study that found it cost an average of $24 million to get FDA approval for a moderate-risk device. If a company creates an application and it does not do what it is supposed to, the FDA can pull it off the market.
Companies with mobile medical apps should decide whether they want to seek FDA approval for something that will diagnose or help treat a disease, or if they will develop something that is geared toward entertainment and wellness, Bergstrom said.
"Are you a medical product or a consumer product?" he said.
Reuters and Baltimore Sun reporter Carrie Wells contributed to this report.
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