BNA’s Health Care Daily Report™ sets the standard for reliable, high-intensity coverage of breaking health care news, covering all major legal, policy, industry, and consumer developments in a...
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.
To contact the reporter on this story: Alex Ruoff in Washington at email@example.com
To contact the editor responsible for this story: Kendra Casey Plank at firstname.lastname@example.org
The FDA guidance is at http://src.bna.com/hd9.
Copyright © 2016 The Bureau of National Affairs, Inc. All Rights Reserved.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)