The U.S. Food and Drug Administration (FDA) announced Tuesday a shift in its regulatory approach to wearable devices and software intended to promote healthy lifestyles. The agency intends to limit its oversight of these products, issuing new guidance to clarify its stance.

According to the FDA, this updated guidance reflects a recognition that many of these devices and software applications are primarily focused on wellness and general health monitoring, rather than diagnosing, treating, or preventing disease. The previous regulatory landscape created uncertainty for manufacturers and innovators in the rapidly expanding health and fitness technology market.

The new guidance outlines which types of devices and software will not be subject to the FDA’s rigorous premarket review process. It clarifies that the FDA will focus its resources on devices that make specific medical claims or pose a higher risk to public health. This includes devices that are used for diagnostic purposes, or those that directly treat or monitor serious medical conditions.

The FDA's decision comes as the market for wearable technology continues to grow, with consumers increasingly using devices like fitness trackers and smartwatches to monitor their activity levels, sleep patterns, and other health metrics. The agency hopes that by reducing regulatory burdens on lower-risk devices, it can encourage innovation and provide consumers with more choices while ensuring the safety and effectiveness of those products that do require FDA oversight.

The agency stated that this shift is not a complete abandonment of oversight. The FDA will continue to monitor the market and may take action if devices or software make misleading claims or pose a significant safety risk. The full guidance document is available on the FDA’s website, providing detailed information for manufacturers and developers.