FDA Clarifies Oversight of Software and Devices Marketed for Digital Wellness Tracking

FDA Guidance Excludes Low-Risk Wellness Technologies From Medical Device Regulation

The FDA does not regulate low-risk general wellness digital health technologies as medical devices. This holds when the products aim only to promote or maintain a healthy lifestyle and avoid any claims to diagnose, treat, prevent or cure diseases. The approach draws directly from the 21st Century Cures Act exclusions for certain software functions, the General Wellness Policy issued in 2019, and coordination by the Digital Health Center of Excellence launched the following year.

The agency established its Digital Health Center of Excellence on September 22, 2020. Officials created the center to advance oversight of digital health technology innovation, including wellness applications. [1]

FDA Policy on Low-Risk General Wellness Products

FDA does not intend to examine or regulate products intended for general wellness that are low risk. That position appears in guidance dated September 27, 2019. [2] The policy covers items that promote or maintain a healthy lifestyle without disease-related claims.

Software Functions Excluded Under Federal Law

Software functions that maintain or encourage a healthy lifestyle are excluded from the device definition under section 520(o) of the 21st Century Cures Act. FDA detailed examples of these functions in guidance updated November 4, 2022. [3] The exclusion covers many mobile apps and tracking tools that stay within wellness and prevention.

Role of the Digital Health Center of Excellence

The center serves as the hub for FDA’s coordinated approach to digital health regulatory policy. It offers a central point for developers seeking clarity on whether their products qualify as medical devices. [1]

What this means

The guidance draws a line between low-risk wellness tools and higher-risk products that make medical claims. This boundary influences how quickly certain digital trackers and apps reach the market. It also allows FDA to concentrate resources on technologies that present greater potential risk.

Key takeaways

• Low-risk digital tools focused solely on wellness and healthy lifestyle choices fall outside FDA device regulation. [2][3]
• The FDA applies a risk-based framework that distinguishes general wellness from diagnostic or therapeutic claims. [2]
• Software functions for maintaining or encouraging a healthy lifestyle are excluded from the medical device definition under the 21st Century Cures Act. [3]
• The Digital Health Center of Excellence coordinates regulatory policy and serves as a centralized resource on digital health oversight. [1]
• No new rulemaking document after 2022 alters the core elements of this framework. [1][2][3]

Limitations

No single new rulemaking document dated after 2022 was identified. The analysis relies on standing guidance documents. Primary regulatory sources do not address long-term real-world evidence on impact to innovation or patient outcomes. The documents also do not cover state-level regulations or international alignment with agencies such as the EMA or Health Canada.

FAQ

What criteria must digital wellness technologies meet to fall outside FDA medical device regulation?
They must be low risk and intended only to promote or maintain a healthy lifestyle without claims to diagnose, treat, prevent, or cure diseases. [2][3]

How does the 21st Century Cures Act affect regulation of software for prevention and wellness?
The law excludes certain software functions related to healthy lifestyle maintenance from the statutory definition of a device. [3]

What guidance does the FDA provide to developers of digital health tools for general wellness?
FDA guidance documents describe examples of wellness software and low-risk products that the agency does not intend to regulate as devices. [2][3]

What is the role of the FDA Digital Health Center of Excellence in this framework?
The center coordinates the agency’s approach to digital health regulatory policy and provides a central resource for innovation and oversight questions. [1]

Sources / References

[1] Digital Health Center of Excellence. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/digital-health-center-excellence

[2] General Wellness: Policy for Low Risk Devices. U.S. Food and Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices

[3] Policy for Device Software Functions and Mobile Medical Applications. U.S. Food and Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-functions-and-mobile-medical-applications