The FDA regulation tightening its grip on wearables has become a defining moment for niche fitness tech companies like WHOOP. In July 2025, the FDA issued a warning letter to WHOOP, Inc., stating that its Blood Pressure Insights (BPI) feature qualifies as an unapproved medical device. This decisive action underscores the growing regulatory scrutiny as wearable technology blurs the lines between wellness gadgets and medical devices.
WHOOP’s BPI, which estimates systolic and diastolic blood pressure based on biometric data, was marketed as a wellness feature, but the FDA considered it a medical device because it is inherently linked to diagnosing or monitoring hypertension and hypotension. This regulatory development signals a shift for smaller wearable device makers, exposing them to increased compliance costs and legal risks while challenging their market positioning and competitive advantage.
What makes this significant is that blood pressure monitoring is a critical health metric, and the FDA’s classification means that devices offering such features must go through rigorous premarket clearance or approval processes. The agency’s warning letter highlighted that failure to comply could lead to injunctions, product seizures, civil penalties, and reputational damage. WHOOP has publicly contested the FDA’s stance, arguing that BPI is a general wellness feature, but the regulatory authority’s position remains firm. This situation exemplifies the urgent need for niche wearable makers to carefully navigate the evolving regulatory landscape or risk severe consequences.
Regulatory Landscape
The regulatory landscape for wearable devices is complex and rapidly evolving. The FDA defines a medical device under the Federal Food, Drug, and Cosmetic Act as any product intended for use in diagnosing, curing, mitigating, treating, or preventing disease or affecting the structure or function of the body. WHOOP’s BPI feature was deemed to meet this definition because it provides blood pressure estimations, which are directly associated with diagnosing cardiovascular conditions.
The FDA’s General Wellness Policy allows certain low-risk wellness products to avoid medical device regulation, but this exemption does not extend to features that provide measurements inherently tied to medical diagnosis or treatment. Blood pressure monitoring falls outside this exemption because it carries significant health implications. WHOOP’s marketing materials describing BPI as providing “medical-grade health & performance insights” further reinforced the FDA’s position.
In contrast, other companies like Aktiia have successfully navigated FDA pathways by obtaining 510(k) clearance for their blood pressure monitoring wearables, backed by clinical trials and compliance with quality system regulations. The European Union’s Medical Device Regulation (MDR) similarly classifies products intended to monitor or predict disease as medical devices, requiring CE marking and ongoing surveillance. This regulatory convergence reflects a global tightening of standards for health-related wearable technologies.
What Happened?
The FDA’s scrutiny of WHOOP’s BPI feature arises from the broader challenge of distinguishing between wellness products and medical devices in an era of sophisticated biometric wearables. As technology advances, features once considered purely wellness-oriented now provide data that can influence medical decision-making. The FDA’s mandate is to protect public health by ensuring that devices claiming to measure critical health parameters meet safety and effectiveness standards.
WHOOP’s decision to market BPI as a wellness feature without FDA clearance triggered regulatory action because blood pressure data is inherently medical and can impact diagnosis and treatment of conditions like hypertension. The agency’s warning letter reflects a consistent enforcement approach emphasizing patient safety, especially when inaccurate readings could lead to harmful health decisions. This regulatory stance also aims to level the playing field among manufacturers, ensuring that companies offering similar health measurement features adhere to the same rigorous standards.
Applicable Regulations, Standards, and Frameworks
The FDA’s classification of WHOOP’s BPI feature as a medical device invokes specific regulatory requirements under the Federal Food, Drug, and Cosmetic Act, particularly sections related to premarket notification (510(k)) and premarket approval (PMA). Noninvasive blood pressure measurement systems fall under 21 CFR § 870.1130 and require clearance before marketing. WHOOP’s failure to submit the necessary applications constitutes a violation that can lead to enforcement actions including product seizures and civil penalties.
WHOOP’s ECG feature, by contrast, has received FDA 510(k) clearance as a Class II medical device, demonstrating the company’s ability to comply with regulatory pathways when pursued. This distinction illustrates the importance of understanding device classification and intended use in regulatory strategy.
Globally, the EU MDR (Regulation 2017/745) mandates that devices intended for diagnosis or monitoring of diseases must undergo conformity assessment, clinical evaluation, and obtain CE marking as Class IIa or higher devices depending on risk. The FDA’s increasing alignment with these standards reflects a trend toward harmonizing medical device regulation internationally.
Impact on Businesses & Individuals
The FDA’s warning letter to WHOOP has profound implications for both companies and consumers in the wearable tech space. For businesses, it means heightened compliance burdens, including conducting clinical trials, enhancing cybersecurity measures, upgrading quality systems, and preparing for FDA inspections. These requirements can significantly increase costs and extend time to market, disproportionately affecting niche firms with limited resources.
Legal risks include injunctions to halt sales, mandatory recalls, civil money penalties, and potential lawsuits from consumers or competitors. WHOOP’s public refusal to remove the BPI feature despite FDA warnings exposes it to these risks, potentially incurring reputational harm and financial penalties.
For consumers, the FDA’s intervention aims to ensure that health-related data provided by wearables is accurate and reliable, reducing the risk of misdiagnosis or inappropriate health decisions based on unverified technology. However, increased regulatory barriers may slow innovation and limit the availability of novel features in fitness trackers, impacting user experience and choice.
Trends, Challenges & Industry Reactions
The WHOOP case highlights a broader industry trend where regulators are intensifying oversight of wearable devices that provide health metrics. Enforcement actions against WHOOP and similar companies signal that the FDA is moving beyond passive monitoring to active enforcement, especially as competitors like Aktiia obtain FDA clearance for similar functionalities.
Industry experts note that companies must now carefully design product claims and intended use statements to avoid triggering medical device classification inadvertently. The debate over the wellness exemption under the 21st Century Cures Act remains unsettled, with legal experts suggesting that courts may ultimately clarify the boundaries.
Manufacturers are increasingly investing in clinical validation, regulatory strategy, and quality management systems to meet FDA and international standards. Some niche firms may find compliance costs prohibitive, leading to market consolidation or partnerships with established medical device companies.
Compliance Requirements
Wearable device makers offering features related to blood pressure or other vital signs must:
- Determine device classification based on intended use and FDA definitions.
- Submit appropriate premarket notifications (510(k)) or premarket approval (PMA) applications supported by clinical data.
- Implement Quality System Regulations (QSR) compliant manufacturing and post-market surveillance.
- Ensure cybersecurity and data privacy protections aligned with FDA guidance.
- Maintain accurate and non-misleading marketing materials consistent with approved indications.
- Prepare for FDA inspections and respond promptly to regulatory inquiries.
Common mistakes to avoid include overstating device capabilities, failing to seek FDA clearance when required, and relying solely on disclaimers to evade regulation.
Future Outlook
The regulatory trajectory suggests that FDA scrutiny of wearable health technologies will intensify, with increasing alignment to international standards like the EU MDR. Companies will need to embed regulatory considerations early in product development to navigate this environment successfully.
Emerging standards around software as a medical device (SaMD), real-world evidence, and digital health interoperability will further shape the landscape. Niche wearable makers that invest in robust clinical validation and regulatory compliance may turn these challenges into market differentiators, while those that resist may face enforcement actions and market exclusion.
Recommendations for companies include engaging with FDA early through pre-submission meetings, investing in clinical trials, developing clear regulatory strategies, and monitoring enforcement trends closely. Transparency with consumers about device capabilities and limitations will also be critical to maintaining trust in this evolving sector.
Ultimately, the WHOOP case serves as a cautionary tale and a catalyst for the wearable device industry to embrace a more disciplined regulatory approach as health and technology converge.
FAQ
1. What triggered the FDA’s warning letter to WHOOP?
Ans: The FDA issued a warning because WHOOP’s Blood Pressure Insights feature was marketed as a wellness tool but actually functions as a medical device by estimating blood pressure, which requires FDA clearance.
2. How does the FDA define a medical device in this context?
Ans: The FDA defines a medical device as any product intended for diagnosing, treating, or preventing disease or affecting body structure or function, which includes devices estimating blood pressure.
3. Can wearable companies avoid FDA regulation by labeling features as wellness?
Ans: Only if the features are demonstrably low risk and unrelated to medical diagnosis or treatment. Blood pressure estimation does not qualify for the general wellness exemption.
4. What are the consequences for companies that market unapproved medical devices?
Ans: They may face injunctions, product seizures, civil penalties, mandatory recalls, and reputational damage, as well as potential lawsuits.
5. How can wearable device makers prepare for increasing FDA scrutiny?
Ans: By conducting clinical trials, submitting appropriate regulatory filings, complying with quality system regulations, ensuring cybersecurity, and maintaining truthful marketing claims.