Senate health committee Chairman Lamar Alexander (R-Tenn.) said the Food and Drug Administration (FDA) is “exactly right to keep your Fitbit or Weight Watchers app free of unnecessary government oversight and red tape.”
“The recent surge of innovative fitness trackers and mobile health apps is good news for Americans who want to take an active role in monitoring and improving their own health,” said Senator Alexander.
“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.”
He continued, “This is welcome guidance from the FDA, and I look forward to seeing the Senate health committee-passed MEDTECH Act signed into law so that this smart policy can soon become law.”
The FDA released a final guidance explaining that the agency “does not intend to actively regulate low-risk technologies that are intended only for general wellness use” and that the FDA “encourages the development of general wellness technologies, such as fitness trackers or mobile apps, which can empower individuals to take a more active role in their health.” Administration guidances are intended to clarify an agency’s position but do not have the force of law.
In March, the Senate health committee overwhelmingly passed The Medical Electronic Data Technology Enhancement for Consumer’s Health (MEDTECH) Act sponsored by Sens. Bennet (D-Colo.) and Hatch (R-Utah) as part of its Senate Cures agenda. This bipartisan bill encourages companies to develop fitness trackers, mobile applications, and other innovative products free from unnecessary FDA oversight and red tape.