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By Alex Ruoff
July 28 — The FDA won't regulate fitness trackers and certain mobile health apps, the agency confirmed in a final guidance document released July 28.
The Food and Drug Administration won't enforce its rules over products that are intended only for general wellness, such as tools for weight management, physical fitness or mental acuity, the agency said. Wellness products can be standalone products or mobile applications, and can also be sold as games, the agency said.
Sen. Lamar Alexander (R-Tenn.), chairman of the influential Senate Health, Education, Labor and Pensions Committee, said in a statement that the guidance is “exactly right.”
“I’m glad to see that the FDA recognizes this and has no current plans to put unnecessary government red tape between people hoping to use a Fitbit to help them get moving or a Weight Watchers application to monitor their diet,” Alexander said. However, Alexander also said the guidance won't undercut the need to pass the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act ( S. 1101), which would exclude from medical device regulations mobile health apps and software commonly used to run a medical practice—such as software for financial records or for clinical laboratory testing that doesn't analyze test data.
Alexander's committee approved the bill in March as part of a package of legislation designed as a companion to the 21st Century Cures bill ( H.R. 6) that the House approved in 2015.
A health-care attorney praised the guidance for clearly defining what technologies are considered wellness products.
While some gray areas still exist, “this at least now finalizes an approach to determine if a good faith argument can be made that any particular product might be a low risk wellness product not subject to FDA regulation, even if the product is designed to provide some health benefits,” Keith A. Barritt, an attorney with Fish & Richardson P.C. of Washington, told Bloomberg BNA in an e-mail.
The FDA has long signaled that it won’t require makers of fitness trackers like Fitbit or Jawbone or developers of mobile health apps that simply track certain health statistics to seek approval from the agency before selling their products. The final guidance released July 28 offers examples of wellness products and is meant to provide technology companies a clearer understanding of which products fall under the FDA's regulatory authority and which products do not.
The agency first published a draft notice outlining its plan to oversee wellness products in January 2015. Industry experts declared it a big victory for mobile medical apps and health information technology developers (12 HCDR, 1/20/15).
The dividing line between general wellness products—which the FDA won't regulate—and medical devices—which the agency does regulate—is whether the technology makes a medical claim, the FDA said in its guidance.
The name of the guidance is General Wellness: Policy for Low Risk Devices. It's officially dated July 29, when the FDA will publish a Federal Register notice about the guidance.
Wellness products track health or wellness issues, such as weight, fitness activity, sleep or sexual activity, the agency said. Any product that claims it can treat or diagnose a disease or condition won't be considered a wellness product, the FDA said.
This distinction is important for app developers, who want to be able to market their products as helpful to people with certain medical conditions but want to steer clear of FDA regulations, which can be time-consuming and expensive, Morgan Reed, executive director of Act, the App Association, told Bloomberg BNA. Products regulated by the FDA must register with the agency, undergo review before they're sold, and meet certain requirement.
“There have been questions about what app makers can say and it left them worried,” Reed said.
The FDA wants to leave wellness products unregulated to promote innovation by technology developers, Bradley Merrill Thompson, an attorney with Epstein Becker & Green P.C., Washington, told Bloomberg BNA. The guidance strikes “the right balance between regulation and innovation,” he said.
The final guidance from the FDA doesn't include many changes from the draft guidance issued in January 2015, which developers found useful, Thompson said.
“Over the intervening year and a half, I have talked to a lot of developers of wearable technologies and associated mobile apps and have used the draft guidance as a roadmap for how to assess FDA jurisdiction,” he said. “I have found it to be extremely practical, and to reach the right conclusion from a societal perspective.”
The FDA will also take into consideration the potential risk of harm a product poses when determining if it is regulated, the agency said. Any technology that is implanted into a person's body or penetrates the skin is likely not considered low-risk and faces regulation.
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The FDA guidance is at http://src.bna.com/hd9.
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