How the FDA Classifies and Reviews Digital Tools for Wellness Tracking

How the FDA Classifies and Reviews Digital Tools for Wellness Tracking

By Helen Whitaker

The U.S. Food and Drug Administration applies a risk-based framework to digital health technologies used for wellness tracking. In its guidance, the FDA has stated it does not intend to regulate low-risk general wellness devices that promote physical fitness, relaxation, or general health without claims to diagnose, treat, prevent, or mitigate specific diseases or conditions [1]. Technologies that do make such claims are evaluated as Software as a Medical Device (SaMD) and may be subject to premarket review depending on risk level [3].

The 21st Century Cures Act narrowed the statutory definition of a device by excluding certain wellness and administrative software functions [2]. The Digital Health Center of Excellence, launched in September 2020, coordinates oversight, offers voluntary engagement programs, and supports innovation across these categories [4].

How the FDA Distinguishes Between General Wellness Products and Regulated Medical Devices

The primary determinant of regulatory status is the nature of the claims made by the product rather than the technology itself. The FDA guidance clarifies that software functions intended only for maintaining or encouraging a healthy lifestyle qualify for exclusion from device regulation under the 21st Century Cures Act when they do not reference specific diseases [2]. Products making disease-related claims undergo evaluation for SaMD status and associated regulatory requirements [3].

What the General Wellness Policy Specifies

The FDA’s 2016 General Wellness: Policy for Low Risk Devices guidance states that the agency does not intend to examine or regulate low-risk general wellness products [1]. This policy applies to tools such as fitness trackers, sleep monitors, and stress-relief applications whose intended uses remain within general health promotion and do not cross into medical claims [1].

Premarket Pathways for Regulated SaMD

When a digital wellness tool meets the definition of SaMD, the FDA applies risk-based classification to determine the appropriate premarket pathway. Class I, II, or III risk levels correspond to 510(k) premarket notification, De Novo classification request, or Premarket Approval (PMA) respectively [4]. The agency has adopted the International Medical Device Regulators Forum (IMDRF) framework for clinical evaluation of SaMD, including those intended for prevention and wellness-related functions [3].

Role of the FDA Digital Health Center of Excellence

The FDA established the Digital Health Center of Excellence in September 2020 to unify its regulatory approach, provide specialized expertise, and accelerate responsible innovation [4]. The Center serves as a central point of contact for developers and promotes early engagement through voluntary pre-submission programs to clarify classification questions [4].

Impact of the 21st Century Cures Act

The 21st Century Cures Act excluded specific categories of software from the statutory definition of a medical device, including functions intended solely for maintaining or encouraging a healthy lifestyle [2]. FDA guidance implementing this legislation clarified that administrative support functions and certain wellness software no longer fall under device oversight, narrowing the scope of regulated digital health products [2].

What this means

FDA policy shows that the majority of consumer wellness tracking tools currently available operate outside medical device regulation when they avoid specific disease claims. Products that assert prevention or treatment functions for identified conditions enter a regulated pathway scaled to their assessed risk. The Digital Health Center of Excellence has centralized coordination of these determinations since 2020, while the 21st Century Cures Act has reduced the overall regulatory footprint for low-risk wellness software.

Limitations

Product-specific classification often requires individual FDA review or legal counsel. Guidance continues to evolve especially for AI/ML-enabled tools. Long-term clinical outcome evidence for many digital prevention technologies remains limited.