FDA enforcement against SeniorLife, Whoop signal new line in the sand for AI health apps

SeniorLife.AI: Diagnostic AI marketed without clearance or controls

In its August 21, 2025 warning letter, FDA cited SeniorLife Technologies Inc. for marketing its SeniorLife.AI mobile application without proper premarket authorization and in violation of multiple provisions of the Federal Food, Drug, and Cosmetic Act (FDCA). The app uses artificial intelligence to assess mobility and cognitive health, including fall risk prediction and early Alzheimer’s detection: functions that FDA determined to be diagnostic in nature.

Although the company registered the app under 21 CFR 890.5360 (Measuring Exercise Equipment), FDA found that the product’s intended use far exceeded the scope of that classification. The agency concluded that SeniorLife.AI is:

• Adulterated under section 501(f)(1)(B) for lacking a PMA or IDE.
• Misbranded under section 502(o) for failing to submit a 510(k).
• Further misbranded under section 502(a) for falsely claiming FDA approval and certification on its website and app store listings.

The app’s promotional materials included statements such as “AI Agents for mobility and cognitive health,” “Proven to reduce falls by 58%,” and “Detect early signs of Alzheimer’s,” which FDA interpreted as diagnostic claims requiring premarket review.

Quality System Regulation (QSR) violations

Beyond the unapproved marketing, FDA’s inspection revealed serious deficiencies in SeniorLife’s compliance with the Quality System Regulation (21 CFR Part 820). These limitations included:

• No Corrective and Preventive Action (CAPA) procedures: The firm had not established procedures for identifying and addressing systemic issues.
• No formal complaint handling system: Complaints were not adequately evaluated to determine whether investigations or Medical Device Reporting (MDR) reporting were necessary. Examples included unresolved software bugs and feature changes that raised concerns about reliability and performance.
• No quality audit procedures: The company had not conducted a single quality audit since its founding in 2022.
• No training procedures or records: Employees lacked documented training to ensure they could perform their assigned responsibilities.

These QSR violations suggest that SeniorLife was operating without the foundational controls required for medical device manufacturers, raising concerns about product reliability, safety, and postmarket vigilance.

Whoop BPI: Blood pressure estimation as a regulated function

In a separate July 14, 2025 warning letter, FDA addressed Whoop’s Blood Pressure Insights (BPI) feature, which estimates systolic and diastolic blood pressure and presents results using a color-coded gauge. FDA concluded that:

• Blood pressure estimation is inherently diagnostic, tied to conditions like hypertension.
• The product’s design and labeling implied a causal link between blood pressure and health outcomes (e.g., sleep quality).
• BPI is not low-risk, and therefore not eligible for exemption under FDA’s General Wellness Policy.

FDA emphasized that even without explicit disease claims, the functionality and context of BPI established its intended use as a medical device. The agency also highlighted the public health risks of inaccurate blood pressure readings, which could lead to inappropriate reassurance or delayed treatment for hypertension.

Regulatory themes emerging from both letters

These enforcement actions reflect a consistent and evolving FDA position on software-based health tools:

1. Intended Use Is Determined by Function and Context. FDA will assess not just what a company says, but how the product behaves, what it measures, and how users interpret the results. Diagnostic functionality—even if framed as “insight” or “wellness”— may well trigger device regulation.
2. Diagnostic Claims Require Premarket Review. Whether it’s estimating blood pressure or predicting cognitive decline, software that performs diagnostic functions must undergo premarket review. Registration under an unrelated classification code will not shield a product from enforcement.
3. Quality System Compliance Is Not Optional. FDA expects even software-only device manufacturers to implement robust QSR controls, including CAPA, complaint handling, audits, and training. The absence of these systems is a red flag for enforcement.
4. Misuse of FDA Branding Is a Serious Offense. Both SeniorLife and Whoop used language or imagery implying FDA approval—an enforcement magnet that undermines public trust and violates FDA’s policy that manufacturers may not imply FDA endorsement of their products.
5. General Wellness Exemptions Are Narrow. Software must truly be unrelated to disease diagnosis or treatment to qualify. FDA is clearly narrowing the scope of what it considers exempt, especially for AI-enabled tools that generate health insights.

What companies should do now

If your company is developing or marketing AI-enabled health software, now is the time to:

• Audit product claims and marketing materials for implied diagnostic intent.
• Reassess device classification and regulatory strategy, especially if your product has evolved beyond its original scope.
• If your product could be viewed as a device,
• implement QSR systems, including CAPA, complaint handling, audits, and training; and,
• establish MDR procedures before launch to ensure postmarket readiness.
• Avoid unauthorized use of FDA logos or approval language, which can trigger immediate enforcement.

FDA’s recent actions suggest that the agency is no longer tolerating ambiguity in the digital health space. If your product uses AI to interpret health data—even in a consumer-facing app—it may be subject to full device regulation.

Authored by Jodi K. Scott