With nearly one out of every five adults in the U.S. using wearable fitness tracking devices, the Food and Drug Administration (FDA) released a guidance communication stating the devices will be exempt from regulations. The FDA will not review low-risk “general wellness products” like fitness trackers and will not require these devices to meet premarket and postmarket regulatory requirements.
The FDA was careful to describe general wellness products as any device with an intended use “related to maintaining or encouraging a general state of health or a healthy activity” or any device that “relates to the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.”
This recent guidance communication falls in line with the FDA’s stance on other health and wellness products like exercise equipment and mobile medical applications. But the FDA isn’t giving manufacturers free range. Manufacturers will not be able to make statements claiming their devices can cure or treat medical conditions, only that their products may help reach fitness goals.
For now, it’s probably best the FDA doesn’t get involved with more devices. The FDA is still trying to understand the best way to regulate 3D printed medical devices with an open draft guidance, but to date, the guidance has only received three comments. Additionally, the FDA just reduced application fees for new medical device applications for 2017 and is likely see an influx as a result.
This past July the FDA also announced a draft guidance that would help eliminate conflicts of interests on advisory panels. With so many changes underway, the FDA doesn’t seem interested in low risk devices so long as they don’t make false claims.